[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Branch Office of \\\"Hadassah Medical Ltd\\\"\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":71},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100601614","feasibility-trial-of-single-dose-radiotherapy-for-localized-low-and-intermediate-risk-prostate-cancer-100601614",false,"NCT07112781","Feasibility Trial of Single-Dose Radiotherapy for Localized Low and Intermediate Risk Prostate Cancer","Feasibility Trial of Single-Dose Radiotherapy for Localized Low and Intermediate Risk Prostate Cancer Using Special System of Internal and External Immobilization for Target Motion Mitigation","FAST-ONE","Inclusion Criteria:\n\n* Signed study specific informed consent form;\n* Histologic confirmation of adenocarcinoma of the prostate by biopsy;\n* Biopsy Gleason score ≤ 7;\n* Up to 6 months of previous hormonal therapy is allowed (but not required);\n* PSA ≤ 20 prior to hormone therapy (if given);\n* No direct evidence of regional or distant metastases after appropriate staging studies (CT, MRI, 68Ga-Prostate-Specific Membrane Antigen (PSMA) Positron emission tomography (PET) \u002F CT)\n* Age ≥ 18;\n* Performance Status 0-2;\n* International Prostate Symptom Score (IPSS) must be ≤ 15 (alpha blockers allowed)\n* Computerized Tomography (CT) or Magnetic Resonance Imaging (MRI) or Ultrasound-based volume estimation of prostate gland ≤ 100 cc\n\nExclusion Criteria:\n\n* Positive lymph nodes or metastatic disease from prostate cancer on imaging studies (CT, MRI, 68Ga-Prostate-Specific Membrane Antigen (PSMA) Positron emission tomography (PET) \u002F CT);\n* Tumour Clinical stage T3 or T4 on MRI;\n* Gleason score \\> 7;\n* PSA \\> 20 ng\u002FmL;\n* Previous pelvic radiotherapy;\n* Previous surgery for prostate cancer;\n* Recent transurethral resection of the prostate (TURP) (less than 3 months);\n* Previous hormonal therapy given for more than 6 months prior to therapy;\n* Prior invasive malignancy unless disease free for a minimum of 3 years;\n* Previous significant urinary obstructive symptoms;\n* Significant psychiatric illness;\n* Ultrasound or CT or MRI estimate of prostate volume \\> 100 cc;\n* Severe, active co-morbidity.\n* Inability to fulfill all dosimetric criteria for target dose coverage and restrictions for the organs at risk according to study protocol;","MALE","18 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this study is to assess the feasibility of high-dose radiotherapy (Single-Dose Radiotherapy, SDRT) of 24 Gy in patients with localized low and intermediate risk prostate cancer using a special system of internal and external immobilization of the prostate gland.\n\nPatients eligible for this study are classified according to the National Comprehensive Cancer Network (NCCN) guidelines as low or intermediate risk prostate cancer (Stage T1-T2c and\u002For Prostate Specific Antigen (PSA) level ≤20 ng\u002FmL and\u002For Gleason score of ≤7).\n\nThe study will examine the technical feasibility of image-guided volumetrically-modulated arc therapy (VMAT-IGRT) with an emphasis on normal tissue sparing and precision of radiation delivery using dedicated devices (an air-filled endorectal balloon and a Foley catheter) that ensure target immobilization and reproducibility of prostate anatomical localization using a special external patient immobilization system, including patient placement on the patient transfer trolley, which allows patient transfer without removing the endorectal balloon and urinary catheter during all stages of simulation and treatment planning (MR, CT, Positron emission tomography (PET) \u002F CT-simulation) and during the treatment session on the linear accelerator.\n\nPreviously untreated patients with localized prostate cancer of the low risk and favorable intermediate risk (NCCN) groups will receive SDRT at a dose of 24 Gy. In patients from the unfavourable intermediate risk (NCCN) group with a visible dominant intraprostatic lesion (DIL), local escalation of the DIL dose to 30 Gy will be performed.\n\nPatients will be followed up at one week and one month after completion of treatment, then every 3 months for 24 months (+\u002F- 4 weeks), and every 6 months thereafter. Evaluation of early and late adverse events will focus, although not exclusively, on the genitourinary and gastrointestinal toxicity, primarily the rectal toxicity. Serum prostate-specific antigen (PSA) levels will be determined according to the clinical follow-up schedule. Multiparametric magnetic resonance imaging (mpMRI) with intravenous contrast will be performed at baseline and at 6-, 12-, and 24-months post-intervention. Participants of the study will be followed up for at least 2 years after treatment.",[27],"Prostate Cancer",[27,29],"Radiotherapy","RECRUITING","2025-08-08",{"date":33,"type":34},"2025-08-13","ACTUAL",{"date":36,"type":34},"2024-07-24",{"date":38,"type":21},"2027-08",{"name":40,"class":41},"Branch Office of \"Hadassah Medical Ltd\"","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":50,"minAge":18,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":54,"conditions":55,"keywords":59,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":42},"100587681","ways-of-retaining-the-inframammary-fold-in-implant-based-breast-surgery-100587681","NCT06931548","Ways of Retaining the Inframammary Fold in Implant-based Breast Surgery","Ways of Retaining the Inframammary Fold in Implant-based Breast Surgery Using Polytetrafluoroethylene (PTFE) Mesh or Allogeneic Dura Mater Graft","Inclusion Criteria:\n\n* White women;\n* Breast cancer stage 0-II;\n* Indications for breast reconstruction;\n* Consent to participate in the study and photographic documentation.\n\nExclusion Criteria:\n\n* Non-white women;\n* Breast cancer stage III-IV;\n* Tubular breast;\n* Mental and cognitive health disorders;\n* Failure to comply with recommendations in the postoperative period (premature physical activity, not wearing compression underwear, missing scheduled visits, refusal of photo documentation);\n* Patient refusal to participate in the study at any stage.","FEMALE",{"count":52,"type":21},100,[24],"There is currently no consensus on the \"gold standard\" for Implant-based Breast reconstruction. In the United States, more than half of all breast reconstructions are performed using acellular dermal matrix (ADM). However, based on the findings of literature and systematic reviews, it can be cautiously said that synthetic meshes cause fewer complications with comparable aesthetic results and low cost. In our study, we propose using polytetrafluoroethylene (PTFE) mesh in implant-based breast reconstruction. This material has previously proven itself in cardiovascular, maxillofacial and neurosurgery, hernioplasty and as a suture material. Allogeneic dura mater, which has demonstrated comparable results in breast reconstruction with the literature, will be used as a comparison. The purpose of this study is to evaluate the efficacy and safety of a porous, non-biodegradable, synthetic polytetrafluoroethylene mesh for implant-based breast reconstruction in patients diagnosed with breast cancer. An allogeneic dura mater technique will be used as a control.\n\nPatients eligible for this study are classified according to the National Comprehensive Cancer Network (NCCN) guidelines as having stage 0-2 breast cancer.\n\nThe primary questions this study aims to answer are:\n\n* What are the rates of major and minor complications associated with these techniques. Major complications will be defined as complications leading to reoperation.\n* How effective are PTFE mesh and dura in maintaining the inframammary fold and implant projection after breast reconstruction?\n* What is the patient satisfaction rate with the surgical results?\n\nPatients will be randomly assigned to the study but will know which technique will be used in their particular case. Patients included in this study will undergo subcutaneous mastectomy or skin-sparing mastectomy using standard techniques with simultaneous implantation using PTFE mesh or allogeneic dura mater graft. In our opinion, the mesh and graft will stabilize the projections of the inframammary fold and breast implant.\n\nAfter the surgery, all minor and major complications will be recorded for 6 months. For this, both physical examination and radiological diagnostic methods will be used, including breast ultrasound and MRI with contrast. Revision surgeries will be performed if necessary.\n\nProjections of the inframammary fold and breast implant will also be measured in order to determine the effectiveness of the compared techniques.\n\nPatients will be asked to complete the BREAST-Q Version 2.0© Reconstruction Module questionnaire to determine satisfaction with the surgical outcome.\n\nThe results of the study will help the professional community to determine the most effective method of Implant-based Breast reconstruction and will be published in peer-reviewed scientific journals.",[56,57,58],"Breast Cancer Stage I","Breast Cancer Stage II","In Situ Breast Cancer",[60,61,62],"implant-based breast reconstruction","breast cancer","PTFE mesh","2025-04-15",{"date":65,"type":34},"2025-04-17",{"date":67,"type":34},"2022-03-01",{"date":69,"type":21},"2026-02",{"name":40,"class":41},""]