[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cancer-pancreas\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cancer-pancreas":37},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,54,86],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":38,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":5},"100598533","phase-2-psilocybin-assisted-psychotherapy-in-cancer-patients-with-adjustment-disorder-100598533",false,"NCT07072728","Psilocybin-Assisted Psychotherapy in Cancer Patients With Adjustment Disorder","A Phase 2b Double-blind, Randomized, Low-dose Comparator-controlled Clinical Trial to Assess the Efficacy and Safety of NPX-5 in Psilocybin-assisted Psychotherapy for the Treatment of Adjustment Disorder Associated With Cancer.","Inclusion Criteria:\n\nTo be eligible for study entry participants must satisfy all of the following criteria:\n\n1. Screening AjD diagnosis (ICD-11), as defined by an ADNM-20 score ≥ 47.5, a score of ≥ 4 on the Distress Thermometer.\n2. Screening HAM-A Score ≥18 (moderate anxiety).\n3. Adults aged 18 to 80 years (inclusive) at screening.\n4. Diagnosed with cancer (exempting those cancers listed in the exclusion criteria) and a minimum life-expectancy of 6 months in the opinion of the treating physician, with performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) scale performed at screening.\n5. Agrees not to commence any new psychiatric medications or psychotherapies from Screening to Week 10.\n6. Able to communicate well and follow study procedures, judged as sufficiently competent with the English language by the investigator, able to build adequate rapport with study staff.\n7. Judged to be of low suicide risk based on Sheehan-Suicide Tracking Scale (S-STS) and the opinion of a research team psychiatrist.\n8. Be medically suitable in the opinion of the investigator as determined by screening for medical problems via a personal interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG), and blood tests.\n9. Have access to a device that is compatible to use the digital technology, i.e smart-phone device or tablet.\n10. Agree not to take any sedating medications for a minimum of 12 hours before the dosing session including benzodiazepines, zopiclone, eszopiclone, zaleplon and zolpidem. Medications for cancer-related pain are permitted.\n11. Must be willing and able to refrain from smoking throughout the duration of the dosing session. Nicotine replacement therapies may be permitted with the agreement of the medical monitor.\n12. Agree that for 1 week before the psilocybin dosing session, participants will refrain from taking any illegal drugs or non-prescription medication (including cannabis, or CBD or THC containing products), nutritional supplement, or herbal supplement except when approved by the study investigators. Additionally, agree not to take any form of psilocybin outside of the study, including microdosing, from baseline through Day 70\u002FWeek 10 (Visit 11).\n13. Participants taking any other medication that is not explicitly detailed as an excluded medication will be discussed with the investigator and medical monitor as appropriate. Decisions on inclusion will be based on clinical judgement and with sufficient justification provided.\n\nExclusion Criteria\n\nParticipants will be excluded from the study if one or more of the following criteria are applicable:\n\nPsychiatric Exclusion Criteria:\n\n1. Current Major Depressive Disorder MDD (or within 12 months of Screening) deemed independent from the cancer diagnosis, current or past diagnosis of schizophrenia, psychotic disorder, unless this was resulting from a medical condition (e.g. lupus or malaria etc.), bipolar disorder I and II, delusional disorder, paranoid personality disorder, schizoaffective disorder, borderline personality disorder, anti-social personality disorder or judged to be incompatible with establishment of rapport or safe exposure to psilocybin, as determined using clinical judgement of past and present medical and psychiatric history by any specialist psychiatrist or registered medical professional under the authorized delegation of a specialist psychiatrist.\n2. First-degree relative with a diagnosed psychotic disorder.\n3. Scores from the screening psychiatrist (or registered medical professional under the authorized delegation of a specialist psychiatrist) and baseline (S-STS) that indicate that the participant is of clinically significant risk of suicide. A decision will be formed based on S-STS scores and used in combination with other clinically significant data at screening. Sites should refer to the medical monitor if required.\n4. Has attempted suicide in the twelve months preceding the screening visit.\n5. Current (\\\u003C 1 year) alcohol or drug misuse as identified as moderate or severe during screening in accordance with Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria, using the MINI 7.0.2, not able or willing to abstain from alcohol consumption in the period 12 hours prior to the dosing session.\n6. Any other reason that might prevent a participant from engaging in therapeutic preparation and integration sessions.\n7. Anyone who has taken a microdose of psilocybin within 5 days of baseline, taken a higher dose of psilocybin (e.g., dried mushrooms or capsules) within 30 days of baseline and experienced euphoria, hallucinations, or altered mental status, or used any classic psychedelics (LSD, ibogaine, ayahuasca, DMT, mescaline) within 3 months prior to baseline.\n\nMedical Exclusion Criteria:\n\n1. Diagnosed with brain metastases, glioblastoma, phaeochromocytoma, bowel obstruction or intestinal failure, active carcinoid syndrome, uncontrolled hypercalcaemia, or uncontrolled diabetes mellitus or insipidus.\n2. Currently taking or planning to take any of the following: any typical or atypical antipsychotic and monoamine-oxidase inhibitors. Participants with prior use of these medications must be willing to discontinue their use for at least 2 weeks prior to the baseline visit and to Day 28.\n3. Currently taking or planning to take any anticonvulsant or mood stabilizer, including carbamazepine, lithium, phenytoin, and valproate. Participants with prior use of these medications must be willing to discontinue their use for at least 1 week prior to the baseline visit and to Day 28.\n4. Any form of fungal allergy.\n5. Positive pregnancy test at screening, women who are breastfeeding or of childbearing potential who are unwilling or unable to use an effective form of contraception (or abstinence) for the study period and for 1 month post NPX-5 dose will be excluded. Women will be required to conduct a serum pregnancy test at the in-person screening visit and urine test prior to dosing session. Male participants who do not agree to use contraception for the study period and for 90 days post NPX-5 dose to mitigate the risk of pregnancy will also be excluded. Note: Refer to Section 4.3.2.1 for further details about contraception.\n6. A diagnosis of epilepsy or at significant risk of seizures based on medical history.\n7. Cardiovascular conditions including stroke and\u002For myocardial infarction (less than one year before providing informed consent), uncontrolled hypertension (blood pressure \\> 140\u002F90 mmHg) or clinically significant arrhythmia at screening. Results are exempt if they are a direct result of the participant's cancer diagnosis and do not present a risk to administration of psilocybin, following discretion of the investigator.\n8. Anyone who, at screening, has clinically significant findings on physical examination, including resting vital signs (HR below 40 or above 120 bpm, blood pressure below 90\u002F60 or above 140\u002F90), ECG (QTcF \\> 450 msec for males and \\>470 for females), and positive alcohol breath test. Note: Inclusion of individuals with any out-of-range values, including blood pressure, is at the discretion of the Investigator.\n9. Liver dysfunction at screening as defined by AST and\u002For ALT \\> 1.5 times the upper level of normal or upper reference range. Results are exempt if they are a direct result of the participant's cancer diagnosis and do not present a risk to the administration of psilocybin, following discretion of the investigator.\n10. Renal Function: estimated glomerular filtration rate \\\u003C60 mL\u002Fmin (calculated using Chronic Kidney Disease Epidemiology Collaboration) unless this is a direct result of the cancer diagnosis and does not present a risk to the administration of psilocybin, following the discretion of the investigator.\n11. Any clinically significant laboratory abnormality(s) that in the opinion of the investigator would present a risk to the administration of psilocybin.\n12. Any clinically significant renal, pulmonary, gastrointestinal, hepatic, or other illness that could affect the interpretation of results or be a potential health risk for the person if they were to be included in the study. Results are exempt if they are a direct result of the participant's cancer diagnosis and do not present a risk to administration of psilocybin, following discretion of the investigator.\n13. Below 18 or above 32kg\u002Fm2 Body Mass Index (BMI) score at Screening.\n14. Anyone with organic brain injury or diagnosed with any cognitive impairment.\n15. Positive urine drug test for non-prescribed psychoactive substances at the dosing session visit. Positive urine drug test for psychoactive substances at the in-person screening should be referred to the medical monitor. Note: Testing may be repeated once at the discretion of the Investigator.\n16. Anyone on a research study of an investigational drug or who has been on a clinical trial within 3 months of enrolment.","ALL","18 Years","80 Years",{"count":20,"type":21},87,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This study is assessing the efficacy and safety of NPX-5 in psilocybin-assisted psychotherapy for the treatment of adjustment disorder due to cancer diagnosis.\n\nWho is it for? This study is for people who are aged between 18 and 80 years old and suffer from anxiety after adjusting to an acutely stressful event of their cancer diagnosis. This is called adjustment disorder.\n\nStudy details Participants in this study will be randomly allocated by chance (similar to flipping a coin) to one of three groups: a 25mg NPX-5 dose group, a 10 mg NPX-5 dose group or a 1mg NPX-5 dose group. Participants will be allocated a dose that will be administered during their psilocybin-assisted psychotherapy (PAP) dosing session. The PAP dosing session will run approximately 8 hours, with NPX-5 administered at Day 14 (dosing day).\n\nAt Week 10, non-responders that continue to meet the study eligibility criteria may commence an additional PAP cycle (at 25 mg NPX-5). A maximum of 2 PAP cycles may be administered. Long term follow up will comprise of a study visit at 3 months post Week 10 (of the final cycle) to assess safety and tolerability of NPX-5.\n\nIt is hoped that this research will develop important scientific knowledge that could contribute to the development of a potential new treatment for anxiety and depression after adjusting to an acutely stressful event such as a cancer diagnosis.",[27,28,29,30,31,32,33,34,35,36,37],"Adjustment Disorder","Adjustment Disorder With Anxious Mood","Cancer","Cancer Cachexia","Cancer of Endometrium","Cancer of Kidney","Cancer of Prostate","Cancer of the Breast","Cancer of Stomach","Cancer Melanoma Skin","Cancer Pancreas",[29,27,39,40,41],"Existential Distress","Psilocybin","Psilocin","RECRUITING","2026-03-01",{"date":45,"type":46},"2026-03-03","ACTUAL",{"date":48,"type":46},"2025-10-01",{"date":50,"type":21},"2027-07-30",{"name":52,"class":53},"Psyence Australia Pty Ltd","INDUSTRY",{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":4,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":61,"targetDuration":63,"studyType":64,"phases":4,"briefSummary":65,"conditions":66,"keywords":70,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":81,"leadSponsor":83,"locationsCount":4},"100606476","expectation-pain-outcomes-and-pain-medication-following-oncology-abdominal-surgery-a-cohort-study-100606476","NCT07176052","Expectation, Pain Outcomes, and Pain Medication Following Oncology Abdominal Surgery: A Cohort Study","Expectation, Pain Outcomes, and Analgesic Efficacy Following Oncology Abdominal Surgery: A Cohort Study","Inclusion Criteria:\n\n* Patients \\> 18 years undergoing elective surgical treatment in the liver, esophagus\u002Fcardia, or pancreas, according to the protocol with curative intent.\n* Patients who can read and understand the Danish language.\n\nExclusion Criteria:\n\n• Patients who are cognitively disabled and cannot mentally cooperate with the study design, as assessed by the investigator.\n\nIn accordance with the Declaration of Helsinki, patients have the right to withdraw from the study at any time for any reason",{"count":62,"type":21},200,"6 Months","OBSERVATIONAL","This study includes participants undergoing major hepatic surgery, surgery in the esophagus or stomach, or major surgery on the pancreas performed at Copenhagen University Hospital, Rigshospitalet. The aims of the study 1: To record patients' level of catastrophizing preoperatively and pain perioperatively, and pain treatment, as well as related side effects. Furthermore, to investigate whether it is possible to assign the task of rating pain scores to the patient.\n\n2\\. To investigate patients' expectations preoperatively and the fulfillment of these expectations 30 days after, and the development of chronic pain after 6 months. 3. To record patients' pre- and postoperatively rated health and daily quality of recovery during the seven days of admission. Furthermore, patients' symptoms, levels of pain, and use of analgesics will be assessed 30 days and six months after discharge.",[67,68,69],"Cancer, Hepatic","Cancer, Esophagus","Cancer, Pancreas",[71,72,73,74,75],"Acute pain","patient expectations","Cancer in the upper abdominal","analgesics","patients self-rating","NOT_YET_RECRUITING","2025-09-09",{"date":79,"type":46},"2025-09-16",{"date":48,"type":21},{"date":82,"type":21},"2027-08-01",{"name":84,"class":85},"Rigshospitalet, Denmark","OTHER",{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":22,"phases":95,"briefSummary":97,"conditions":98,"keywords":101,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":114},"100595017","early-phase-1-ga-68mtp220-pet-for-biodistribution-and-efficacy-in-pancreatic-cancer-and-head-and-neck-cancers-100595017","NCT07026981","[Ga-68]MTP220 PET for Biodistribution and Efficacy in Pancreatic Cancer and Head and Neck Cancers","Exploratory, Prospective, Single-Arm, Open-labeled Study of [Ga68]MTP220 PET for First-in-Human Biodistribution and Efficacy in Patients With Pancreatic Cancer and Head and Neck Cancers","Inclusion Criteria:\n\n* Participants older than 18 years old\n* Prior biopsy showing pancreatic or head and neck malignancy\n* Participants have been newly diagnosed and not yet received definitive therapy (including surgery, radiation therapy, or systemic therapy).\n* Able and willing to provide written informed consent before any protocol-specific procedures are undertaken\n* Participants willing and able to undergo a PET\u002FCT\n\nExclusion Criteria:\n\n* Participants who do not meet the above mentioned inclusion criteria\n* Participants with severe hepatic and renal dysfunction (Total bilirubin \\> 3 mg\u002FdL, Albumin \\\u003C 2.8 g\u002FdL, INR \\> 2.3 (or prolonged PT), presence of ascites or hepatic encephalopathy (Grade III-IV) End-Stage Renal Disease (ESRD) or eGFR \\\u003C 30 mL\u002Fmin\u002F1.73m², Serum creatinine \\> 4 mg\u002FdL or rapidly rising, Need for dialysis (hemodialysis or peritoneal dialysis), uremic symptoms)\n* Participants \\\u003C 18 years old\n* Participants who refuse to give or are unable to sign the informed consent\n* Anti-cancer treatment (chemotherapy and\u002For radiation therapy) within the last 2 weeks\n* Participants unable to withstand or undergo PET\u002FCT\n* Pregnant or breast feeding women.",{"count":94,"type":21},12,[96],"EARLY_PHASE1","The goal of this research study is to develop a diagnostic tool to help with detection and diagnosis of head and neck cancer (HNC) and pancreatic cancer (PaC). This tool is called a \"targeted PET tracer\", or more specifically a drug named \"\\[Ga-68\\]MTP220\". The U.S. Food and Drug Administration (FDA) has not yet approved this drug, so researchers are conducting this research study to see if \\[Ga-68\\]MTP220 is safe and effective at diagnosing pancreatic cancer and head and neck cancer. FDA approval has been obtained for this study protocol by an Investigational New Drug (IND) application. Participants will receive a single injection of \\[Ga-68\\]MTP220 followed by PET\u002FCT imaging at three points after they received the drug. These study procedures will take about 2.5 hours. Participants will also receive a follow-up phone call the day after receiving the drug to talk about any side effects they experienced.",[99,100,37],"Head and Neck Cancer","Pancreatic Cancer",[102,103,104],"[Ga68]MTP220","Positron Emission Tomography Computed Tomography","PET CT Scan","2025-08-07",{"date":107,"type":46},"2025-08-08",{"date":109,"type":21},"2025-09",{"date":111,"type":21},"2026-12-31",{"name":113,"class":85},"Qiubai Li",1]