[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"prostate-cancer-surgery\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:prostate-cancer-surgery":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,45,81,106,131,161,197],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100581379","phase-2-phase-ii-trial-to-investigate-the-safety-and-efficacy-of-four-dosing-regimens-of-otl78-injection-100581379",false,"NCT06849544","Phase II Trial to Investigate the Safety and Efficacy of Four Dosing Regimens of OTL78 Injection","Phase II Trial to Investigate the Safety and Efficacy of Four Dosing Regimens of OTL78 Injection (Zopocianine), a Prostate-Specific Membrane Antigen (PSMA)-Targeted Fluorescent Agent, for the Intraoperative Imaging of Prostate Cancer","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent and HIPAA form\n2. Male subjects 18 years of age and older\n3. Known primary prostate cancer and Grade Group 3 to 5 (≥ cT3) or one or more of the following:\n\n   1. Suspected extraprostatic disease (EPD) (extracapsular extension (ECE) and\u002For seminal vesicle infiltration (SVI)),\n   2. 3 or more biopsy cores of grade group 3-5;\n   3. Suspected lymph node metastasis (clinical stage cN1, or by magnetic resonance imaging (mriN+), or by Prostate Specific Membrane Antigen positron emission tomography (PSMA PET+));\n4. Planned to undergo a standard of care robotic prostatectomy and lymph node dissection\n5. Ability to understand the requirements of the study and agree to abide by the study restrictions and to return for the required assessments\n6. Agree to use a medically acceptable method of birth control (e.g., spermicide in conjunction with a barrier such as a condom) or sexual abstinence for the duration of the study, including through final study visit (6 weeks) after the dose of study drug. Sperm donation is prohibited during the study and for 3 months after the dose of study drug. Female partners must use hormonal or barrier contraception unless postmenopausal or abstinent.\n\nExclusion Criteria:\n\n1. The surgeon plans to perform an extraperitoneal approach\n2. History of anaphylactic reactions to products containing indocyanine green\n3. History of allergy to any of the components of ZOPOCIANINE:\n\n   1. 2-\\[3-(1,3-dicarboxypropyl)ureido\\] pentanedioic acid (DUPA)\n   2. Polyethylene glycol-dipeptide linker\n   3. Chlorodye\n4. Impaired renal or hepatic function:\n\n   1. Renal: creatinine clearance (eGFR) \\\u003C 50 mL\u002Fmin\n   2. Hepatic: total bilirubin \\> 2 × upper limit of normal or ALT\u002FAST \\> 3 × upper limit of normal.\n5. Patients with QTc interval ≥ 470 msec per electrocardiogram (ECG) at screening.\n6. Significant acute or chronic medical, neurologic, or illness in the subject that, in the judgment of the Principal Investigator, could compromise subject safety, limit the ability to complete the study, and\u002For compromise the objectives of the study","MALE","18 Years",{"count":19,"type":20},22,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This study is being done to compare how well Zopocianine (OTL78) in combination with Near InfraRed (NIR) fluorescent imaging may improve the detection of malignant (growing in an uncontrolled way) tissue in adult subjects undergoing prostatectomy and lymph node dissection for biopsy confirmed prostate cancer.",[26,27],"Prostate Cancer Surgery","Prostate Cancer Metastatic Disease",[29,30,31],"Prostate Specific Membrane Antigen","Fluorescent Imaging","Near infrared imaging","RECRUITING","2026-04-30",{"date":35,"type":36},"2026-05-05","ACTUAL",{"date":38,"type":36},"2025-04-02",{"date":40,"type":20},"2026-08",{"name":42,"class":43},"Clinton Bahler","OTHER",3,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":56,"conditions":57,"keywords":60,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":80},"100564618","phase-1-neoadjuvant-darolutamide-and-relugolix-combination-preceding-radical-prostatectomy-for-prostate-cancer-100564618","NCT06631521","Neoadjuvant Darolutamide and Relugolix Combination Preceding Radical Prostatectomy for Prostate Cancer","Neoadjuvant Darolutamide and Relugolix Combination Preceding Radical Prostatectomy for High Risk Localized and Locally Advanced Prostate Cancer: A Phase I\u002FIb Trial","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed adenocarcinoma of the prostate\n2. ECOG performance status 0-1\n3. Ability to swallow oral medications and comply with study procedures and requirements.\n4. Males ≥18 years\n5. Participants must have adequate organ and marrow function as below:\n\n   1. Absolute neutrophil count (ANC) ≥1,500\u002Fmm3 or ≥1.5 x 109\u002FL;\n   2. Platelets ≥100,000\u002Fmm3 or ≥100 x 109\u002FL;\n   3. Hemoglobin ≥8 g\u002FdL (may have been transfused).\n   4. Estimated creatinine clearance ≥30 mL\u002Fmin as calculated using the Cockcroft-Gault equation.\n   5. Total serum bilirubin \\<1.5 x upper limit of normal (ULN), less than 2.0 x ULN if suspected Gilbert's syndrome;\n   6. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 2.5 x ULN.\n6. Must be a candidate for RP\n7. Clinical stage cT2-4, N0-1\n8. Mandatory to identify tumor availability (≥10 FFPE slides, 5 µM thickness \\& 1 stained H\\&E slide OR tumor block)\n9. High-risk PCa defined as one of the following-\n\n   * Gleason score (GS) ≥ 4 + 3 with ≥ 6 positive systematic biopsies (SB)\n   * GS ≥ 4 + 3 with ≥ 3 SB and prostate-specific antigen (PSA) ≥ 20 ng\u002FmL\n   * GS ≥ 9 in ≥ 1 SB or targeted biopsies (TB) -≥ 2 SB or TB with continuous GS ≥ 8, each with ≥ 80% involvement.\n\nExclusion Criteria:\n\n1. Histologic variants including neuroendocrine differentiation, small cell, sarcomatoid, ductal adenocarcinoma, squamous or transitional cell carcinoma) comprising more than 50% of the sample as determined by pathology review\n2. Participants who have had chemotherapy or radiotherapy within 4 weeks prior to planned cycle 1 day 1 of study treatment.\n3. Participants who have received anti-neoplastic intervention or experimental antineoplastic therapy within 14 days of planned cycle 1 day 1 of study therapy.\n4. Participants who are receiving any other investigational agents.\n5. Participants who have previously received darolutamide, relugolix, LHRH agonist\u002Fantagonist or another novel androgen blocking therapy (abiraterone, apalutamide, enzalutamide) within 1 year are excluded (prior bicalutamide that was discontinued ≥14 days prior to planned cycle 1 day 1 is allowed).\n6. Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e. have residual toxicities ≥Grade 2) with the exception of alopecia.\n7. Any of the following within 6 months before planned cycle 1 day 1 of study therapy:\n\n   * Stroke\n   * Myocardial infarction\n   * Severe\u002Funstable angina pectoris\n   * Coronary\u002Fperipheral artery bypass graft\n   * Congestive heart failure New York Heart Association (NYHA) Class III or IV.\n8. Known or suspected contraindications, hypersensitivity or allergy to darolutamide or relugolix or to any of their excipients.\n9. Participants with hepatitis C, hepatitis B or human immunodeficiency (HIV) who are on anti-viral therapy that has the potential to interact with darolutamide or relugolix.\n10. Participants treated with drugs known to be strong inhibitors and\u002For inducers of cytochrome P450 3A4 (CYP3A4) and the treatment cannot be discontinued or switched to a different medication at least 5 half-lives prior to starting study drug.\n11. NOTE: precaution is warranted with concomitant use of agents with a narrow therapeutic index that are substrates of P-gp, BCRP and OCT1.\n12. The participant has serious and\u002For uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment \\[e.g. estimated creatinine clearance less than 30ml\u002Fmin\\], history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea).\n13. Concurrent active malignancy whose natural history or treatment has the potential to interfere with safety or efficacy assessment of the investigational regimen. Patients with non-melanomatous skin cancer, superficial bladder cancer, cancer not needing active therapy for at least 2 years, cancer for which the treating investigator deems the subject to be in remission, or any prior malignancy that was treated with curative intent (no evidence of disease for at least 3 years) are permitted to enroll.",{"count":53,"type":20},30,[55],"PHASE1","The goal of this clinical trial is to determine the safety and feasibility of a new combination of darolutamide and relugolix as neoadjuvant therapy preceding radical prostatectomy (RP) for high-risk prostate cancer (PCa) in adult males.",[58,59,26],"Prostate CA","Prostate Cancer (Adenocarcinoma)",[61,62,63,64,65,66,67,68,69,70],"Prostate Cancer","High-Risk Prostate Cancer","Neoadjuvant Therapy","Radical Prostatectomy","Darolutamide","Relugolix","Androgen Receptor Antagonists","Gonadotropin-Releasing Hormone Antagonists","Clinical Trial Phase I\u002FIb","PSA Response","2026-02-03",{"date":73,"type":36},"2026-02-05",{"date":75,"type":36},"2024-10-22",{"date":77,"type":20},"2026-06",{"name":79,"class":43},"AdventHealth",1,{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":21,"phases":90,"briefSummary":92,"conditions":93,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":105},"100579296","prospective-comparative-study-evaluating-the-early-complications-of-robot-assisted-radical-prostatectomy-performed-as-an-outpatient-versus-an-inpatient-procedure-100579296","NCT06822452","Prospective Comparative Study Evaluating the Early Complications of Robot-assisted Radical Prostatectomy Performed as an Outpatient Versus an Inpatient Procedure.","PROSTAMBU","Inclusion Criteria:\n\n* Male, aged 18 and over\n* Patient with prostate cancer for which the multidisciplinary meeting has proposed radical prostatectomy as a therapeutic option (with or without lymphadenectomy)\n* Patient eligible for outpatient treatment :\n\n  1. The patient undertakes to comply with all medical instructions given during surgical consultations and the anaesthetic consultation.\n  2. The patient has access to personal transport allowing, if necessary, return to the facility or another approved facility (transport time and distance from the facility are not exclusion factors)\n  3. The patient has access to telephone communication facilities.\n  4. The patient undertakes not to drive a vehicle and to be accompanied on his return home and for the next 24 hours by a responsible person who will be familiar with the monitoring instructions.\n  5. The patient plans to remain in hospital overnight if this is deemed necessary by the department's doctors (operator and anaesthetist). The patient accepts this mode of care and its constraints.\n* Participant affiliated to or benefiting from a social security scheme\n* The participant has been informed and has given his\u002Fher free, informed and written consent (at the latest on the day of inclusion and before any examination required by the research).\n\nExclusion Criteria:\n\n* Patient already treated for prostatic carcinoma with brachytherapy, radiotherapy or focal therapy\n* Patient participating in ongoing research or in a period of exclusion at the time of inclusion\n* Refusal or inability to comply with the study protocol for any reason whatsoever\n* Protected participant: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision.",{"count":89,"type":20},510,[91],"NA","The goal of this clinical trial is to demonstrate that outpatient management for robotic-assisted radical prostatectomy is not inferior to inpatient management in terms of the occurrence of early post-operative complications.\n\nResearchers will compare outpatient robot-assisted radical prostatectomy to inpatient procedure.\n\nParticipants will:\n\n* Visit the clinic after the operation once at 45 days, 6 months and once a year for up to 5 years for check-ups and tests.\n* Answer survey questions about urinary and erectil functions, stress and anxiety, satisfaction, quality of life for 6 months\n* Keep a diary to record procedures and treatments related to the care provided",[26,94,95],"Ambulatory Care","Outpatient Surgery","2025-07-07",{"date":98,"type":36},"2025-07-08",{"date":100,"type":36},"2024-12-30",{"date":102,"type":20},"2030-04-30",{"name":104,"class":43},"Elsan",12,{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":21,"phases":115,"briefSummary":116,"conditions":117,"keywords":119,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":130},"100575737","extended-vs-no-pelvic-lymph-node-dissection-during-radical-prostatectomy-dissection-20-100575737","NCT06776172","Extended vs. No Pelvic Lymph Node Dissection During Radical Prostatectomy. DISSECTION 2.0.","Extended Pelvic Lymph Node Dissection vs. No Pelvic Lymph Node Dissection at Radical Prostatectomy in PSMA PET Negative Staged Men: A Multicenter, Randomized Phase III Trial","Inclusion Criteria:\n\n* Age ≥ 18 years and life expectancy \\>15 years\n* Any biopsy-proven WHO\u002FISUP grade groups III-V PCa\n* High-risk prostate cancer defined as:\n\n  * Any biopsy-proven WHO\u002FISUP grade group III-V PCa or\n  * ISUP grade group II and PSA \\> 20 ng\u002Fml\n* PSMA-PET: negative staging for regional and distant metastasis\n* multidisciplinary tumorboard recommendation for radical prostatectomy\n* WHO performance status 0-1\n* Adequate condition (ASA ≤ III) for general anesthesia and RP\n\nExclusion Criteria:\n\n* ISUP grade group I PCa and cT1 or cT2 (MRI)\n* cT4 (MRI) PCa\n* PSMA-PET: positive staging for local and distant metastasis\n* Any prior neoadjuvant, local or systemic treatment for PCa\n* Previous PLND or pelvic radiotherapy\n* Patients with a prior malignancy and treated with curative intention are eligible if all treatment of that malignancy was completed at least 2 years before registration and the patient has no evidence of disease at registration. Less than 2 years is acceptable for malignancies with low risk of recurrence and\u002For no late recurrence.\n* Any other serious underlying medical, psychiatric, psychological, familial, or geographical\n* condition, which in the judgment of the investigator may interfere with the planned\n* staging, treatment and follow-up, which affect patient compliance or place the patient at\n* high risk from treatment-related complications.\n* Vulnerable men (participants incapable of judgment or participants under tutelage) will not be included in the study.",{"count":114,"type":20},400,[91],"The aim of the DISSECTION 2.0 study is to determine whether extended pelvic lymph node dissection (ePLND) provides a therapeutic benefit for high-risk prostate cancer patients by improving cancer staging and potentially removing micrometastatic disease, ultimately improving their outcomes.",[26,118],"Prostate Cancers",[120],"Pelvic Lymph Node Dissection","2025-06-30",{"date":123,"type":36},"2025-07-03",{"date":125,"type":36},"2025-02-10",{"date":127,"type":20},"2040-02",{"name":129,"class":43},"University Hospital, Basel, Switzerland",15,{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":137,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":140,"phases":4,"briefSummary":141,"conditions":142,"keywords":146,"overallStatus":151,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":4},"100578727","state-of-play-of-physiotherapy-in-the-postoperative-management-of-prostate-cancer--prospective-monocentric-national-survey-aiming-to-explore-the-technics-of-physiotherapy-predukin-100578727","NCT06815055","State of Play of Physiotherapy in the Postoperative Management of Prostate Cancer : Prospective, Monocentric, National Survey, Aiming to Explore the Technics of Physiotherapy (PREduKiné)","PREduKiné State of Play of Physiotherapy in the Postoperative Management of Prostate Cancer : Prospective, Monocentric, National Survey, Aiming to Explore the Technics of Physiotherapy","PREduKiné","Inclusion Criteria:\n\n* men who has undergone a radical prostactectomy to treat a prostatic adenocarcinoma\n* having a follow up postoperative consultation between one and two month after the surgery\n* being able to answer to respond the questions during the interviews\n* agreeing to participate by signing informed consent form\n\nExclusion Criteria:\n\n* undergoing an adjuvant therapy as radiotherpy, chemotherapy and hormone therapy\n* Refusing to take part in the study",{"count":89,"type":20},"OBSERVATIONAL","In France, a considerable number of radical prostactectomy for cancer is carried out every year.This number was estimated at 20.000 in 2016.This surgery may have negative impact on the continence's subjects and their quality of life. The rehabilitation, preoperative or postoperative, practiced by a physiotherapist, can reduced those side effects. The rehabilitation techniques are many and their efficacy may differ.\n\nNo study where found about the clasification and evaluation of those rehabilitation techniques.",[143,144,61,26,145],"Radical Prostatectomies","Rehabilitation Outcome","Rehabilitation Exercise",[147,148,149,150],"radical prostatectomy","rehabilitation","continence","quality of life","NOT_YET_RECRUITING","2025-06-02",{"date":154,"type":36},"2025-06-05",{"date":156,"type":20},"2025-06-01",{"date":158,"type":20},"2026-12-30",{"name":160,"class":43},"Centre Hospitalier de Roubaix",{"id":162,"slug":163,"hasResults":11,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":4,"eligibilityCriteria":167,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":168,"enrollmentInfo":169,"targetDuration":4,"studyType":21,"phases":171,"briefSummary":172,"conditions":173,"keywords":177,"overallStatus":151,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":80},"100586479","robotic-prostatectomy-artificial-intelligence-low-pressure-pain-ralp-trial-100586479","NCT06915909","Robotic Prostatectomy Artificial Intelligence Low Pressure Pain (RALP) Trial","Robotic Prostatectomy Artificial Intelligence Low Pressure Pain Study Trial - \"The Monitoring of Patients Outcomes Intraoperatively and Perioperatively Using the Airseal and Stryker Insufflator Undergoing Robotic Assisted Laparoscopic Prostatectomy at a Pressure and Stability of Pneumoperitoneum of 8 mmHg\"","Inclusion Criteria:\n\n* Patient indicated for non-emergent robotic Prostatectomy surgery\n* Patients (or appropriate legal representatives) able to provide written informed consent to participate in the study\n* Males, aged 18 to 75 years\n* Have no significant psychopathology that could limit the subject's ability to understand the procedure, comply with medical, surgical, and\u002For behavioural recommendations and office visits\n* Are American Society of Anaesthesiologists (ASA) Class I, II, or III);\n\nExclusion Criteria:\n\n* Patient participation in a different investigational clinical study within 90 days before screening and for the duration of this trial (unless previously approved by the investigator and Sponsor);\n* Patients requiring any surgical procedure in addition to Prostatectomy and or \u002F Pelvic Lymph node dissection\n* Previous pelvic surgery or previous malabsobtion or restrictive procedures performed for the treatment of obesity\n* Inability to provide informed consent\n* Unable or unwilling to attend follow-up visits and examinations\n* Uncontrolled hypertension (=\u002F\\>Systolic: 180 mmHg\u002FDiastolic: 120 mmHg) and\u002For diabetes mellitus (Blood sugar level: \\>200 mg\u002FdL)\n* Patients who fall into American Society of Anesthesiologists (ASA) Class ≥ IV\n* History of chronic alcohol or drug abuse within 2 years of the screening visit\n* Chronic renal failure or on dialysis\n* Significant complicating medical history or immunocompromised\n* History or presence of pre-existing autoimmune connective tissue disease, e.g., systemic lupus erythematosus or scleroderma\n* Immunocompromised such as that resulting from chronic oral steroid use, chemotherapeutic agents, or immune deficiency disorders;\n* Any medical condition which precludes compliance with the study\n* Subjects with any other clinically significant unstable medical disorder, life threatening disease, or conditions that, in the opinion of the investigator, may jeopardize the subject's well-being and\u002For the soundness of this clinical study or which would contra-indicate a surgical procedure.\n* Previous or current history of being on regular analgesia \u002F pain killers","75 Years",{"count":170,"type":20},40,[91],"The 'Robotic Prostatectomy Artificial Intelligence Low Pressure Pain Study Trial' aims to assess the feasibility of being able to review operative outcomes such as pain when comparing two commonly used surgical devices for the removal of prostate cancers. The data collected will inform methodologies for future, larger, multi-center trials investigating pain in patients undergoing prostate cancer surgery.\n\nA robotic prostatectomy is a commonly performed surgery used to treat prostate cancer by removing the prostate gland. In order to perform the procedure, the surgeon must 'inflate' (technical term pneumoperitoneum) the patients abdomen with carbon dioxide gas using a device called an insufflator. Adequate 'inflation' of the abdomen ensures the surgeon can clearly visualise the prostate. Unfortunately, higher pressures of abdominal 'inflation' are a large contributor to intra and post-operative pain in patients having prostatectomies. The type of insufflator device used to maintain inflation pressures in the abdomen are thought to be a variable contributing to differing levels of intra and post-operative pain. Therefore, the purpose of this trial is to compare intra and post-operative pain when using two different insufflator devices when performing robotic prostatectomies. Both insufflators are already commonly used across multiple NHS Trusts.\n\n40 patients awaiting a robotic prostatectomy at the urology department at the Lister hospital, Stevenage, will be randomised to use either the Conventional Insufflator System (CIS) {Stryker PneumoClear Insufflator} or the AIRSEAL® Insufflation System (AIS) to 'inflate' their abdomens during their prostatectomies. Data relating to various intra and post-operative outcomes will be collected in the 30 days following the patient's operation. Outcomes include levels of intra and post-operative pain, medication use, procedure time, recovery room time, length of hospital stay, post operative nausea and vomiting and adverse events. This data can be analysed to identify trends in differences in outcomes between the AIS and CIS insufflators.",[59,174,26,118,175,176],"Prostate Cancer (Post Prostatectomy)","Prostate Neoplasm","Prostatectomy",[178,179,180,181,182,183,184,185,186],"prostate cancer","prostatectomy","robotic prostatectomy","post-operative pain","pain","Stryker PneumoClear insufflator","AirSeal Insufflation System","intra-operative pain","Medasense","2025-03-31",{"date":189,"type":36},"2025-04-08",{"date":191,"type":20},"2025-04-01",{"date":193,"type":20},"2025-07-01",{"name":195,"class":196},"East and North Hertfordshire NHS Trust","OTHER_GOV",{"id":198,"slug":199,"hasResults":11,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":4,"eligibilityCriteria":203,"healthyVolunteers":11,"sex":204,"minAge":17,"maxAge":4,"enrollmentInfo":205,"targetDuration":4,"studyType":21,"phases":207,"briefSummary":208,"conditions":209,"keywords":222,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":80},"100580294","high-resolution-pet-ct-specimen-imaging-for-the-perioperative-visualization-of-resection-margins-100580294","NCT06835426","High-resolution PET-CT Specimen Imaging for the Perioperative Visualization of Resection Margins","High-resolution PET-CT Specimen Imaging for the Perioperative Visualization of Resection Margins: an Exploratory Pilot Study","A. Inclusion Criteria:\n\n* able to understand treatment protocol and informed consent form\n* estimated by the investigator to be compliant for study participation\n\n  1\\. Fulfilling all group-specific inclusion criteria:\n* confirmed breast cancer with an indication to undergo breast conserving surgery\n* confirmed prostate cancer with an indication to undergo resective surgeryprostatectomy;\n* confirmed thyroid lesion with an indication to undergo resective surgery;\n* confirmed parathyroid adenoma with an indication to undergo resective surgery;\n* suspected basal cell carcinoma, squamous cell carcinoma or melanoma with an indication to undergo resective surgery;\n* suspected lesion in genitourinary sites (including bladder cancer, renal pelvis and ureter carcinoma, adrenal cortical carcinoma and renal cell carcinoma) with an indication to undergo resective surgery;\n* suspected lesion in the head \\& neck region with an indication to undergo resective surgery;\n* confirmed primary or secondary hepatobiliary cancer with an indication to undergo resective surgery;\n* patients undergoing biopsy after metabolic active lesions were detected on a PET scan.\n* suspected neuro-endocrine malignancies with an indication to undergo resective surgery.\n* suspected brain tumor with an indication to undergo resective surgery.\n* Suspected malignant and benign gastrointestinal lesions with an indication to undergo resective surgery.\n* suspected malignant thoracovascular lesions with an indication to undergo resective surgery\n\nB. Exclusion Criteria:\n\n* general or local contra-indications for resective surgery;\n* in case of FDG-based PET tracers: a blood glucose level over 200 mg\u002FdL on the day of surgery;\n* pregnancy or lactation;\n* participation in other clinical studies with a radiation exposure of more than 1 mSv in the past year.","ALL",{"count":206,"type":20},150,[91],"These are patients in whom a benign or malignant tumor was recorded requiring surgery. During that surgery, the surgeon will cut away the tumor as part of the treatment of the disease. In this process, it is important that the tumor is removed correctly and completely. To verify that the correct tissue was completely removed, the tissue is examined microscopically. However, a microscopic analysis takes a relatively long time and the result is not known until a few days after the surgery is completed. If that microscopic analysis should eventually reveal that the tumor was not completely removed, additional treatment is usually necessary. An assessment of the excised tissue during surgery would allow additional tissue to be excised in the same operation if necessary. Thus, in this way, additional treatments can also be avoided. This could lead to shorter treatment time and less emotional strain for the patient, as well as lower costs. To date, however, there are no effective techniques to do this.\n\nPositronEmissionTomography (PET) imaging can be used to image the tumor that needs to be excised. To do this, a tracer must be administered through the blood before the operation. This tracer is a slightly radioactive substance that can be detected by the PET camera even at low concentrations. This technique is already routinely used in the hospital to detect cancer or inflammatory tissue in the body. During this study, however, it's not the intention to look at the tumor while it is still in the patient's body, but rather after it has been cut out of the patient's body by the surgeon. To do this, the piece of tissue cut away will be scanned using a specially designed PET-CT scanner.\n\nThe overall goal of this study is to gain additional knowledge. More specifically, the investigators wish to determine which medical conditions may benefit from high-resolution PET-CT specimen imaging.",[210,26,211,212,213,214,215,216,217,218,219,220,221],"Breast Carcinoma","Thyroid Cancer","Parathyroid Adenomas","Skin Cancer","Genitourinary Cancer","Head and Neck Cancer","Hepatobiliary Cancers","Metabolic Abnormality","Neuro Endocrine Tumours","Brain Tumours","Gastro Intestinal Cancer","Thoracoscopic Surgery",[223,224,225,226,227,228,229,230,231,232],"resective surgery","perioperative high-resolution PET-CT specimen imaging","breast cancer","Prostate cancer","thyroid cancer","parathyroid cancer","head and neck cancer","neuro-endocrine malignancies","genitourinary malignacies","thoracovascular malignancies","2025-02-14",{"date":235,"type":36},"2025-02-19",{"date":237,"type":36},"2023-08-06",{"date":239,"type":20},"2027-06-30",{"name":241,"class":43},"Algemeen Ziekenhuis Maria Middelares"]