[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585592":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":17,"studyPopulation":21,"armGroups":22,"interventions":29,"overallOfficials":41,"centralContacts":45,"locations":50,"responsibleParty":88,"collaborators":90,"id":94,"slug":95,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":96,"sex":102,"minAge":103,"maxAge":104,"enrollmentInfo":105,"targetDuration":17,"studyType":108,"phases":17,"briefSummary":109,"conditions":110,"keywords":123,"overallStatus":52,"whyStopped":17,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":137},{"fullName":5,"class":6},"Washington University School of Medicine","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence of ovarian visualization","Defined as being able to delineate at least one ovary (if only one is visible, must be the same ovary) for ≥60% of CBCT sessions per patient.","Estimated to be 5 days",[14],{"measure":15,"description":16,"timeFrame":12},"Incidence of dosimetrically sparing one or both ovaries from a functionally ablative radiation dose","Defined as maintaining a cumulative \\>95% coverage of planned tumor volume (PTV) with 95% of the prescription dose (25 Gy\u002F5 fx) while delivering no more 6 Gy to the ovaries per patient. If only one ovary can meet constraints it must be the same ovary over all fractions.",null,{"allocation":17,"interventionModel":17,"interventionModelDescription":17,"primaryPurpose":17,"observationalModel":19,"timePerspective":20,"maskingInfo":17},"COHORT","PROSPECTIVE","This study will enroll patients at Siteman Cancer Center at Washington University School of Medicine.",[23],{"label":24,"type":17,"description":25,"interventionNames":26},"Ovarian-Sparing Adaptive Radiotherapy","A 25 Gy \u002F 5 fx rectal plan for all patients, irrespective of their primary malignancy, will be created as per institutional standards. Patients may undergo treatment on any radiation therapy machine but will have their pelvis images on a HyperSight CBCT machine after consent while they receive their treatment. In general, patients will be imaged with 2 CBCTs approximately 10 minutes apart, each imaging session \u002F day. However, only one CBCT per treatment session is required, and a patient may have between 1 to 10 scans total throughout 1 to 5 imaging sessions. In general, if ovaries are well visualized then only 1 or 2 imaging sessions will be completed.",[27,28],"Device: HyperSight cone beam computed tomography (CBCT) scan","Device: ETHOS 2.0",[30,37],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"DEVICE","HyperSight cone beam computed tomography (CBCT) scan","HyperSight is a novel onboard imaging platform with a rapid-acquisition high-quality CBCT imager capable of acquiring images sufficient for simulation and treatment.",[24],[36],"CBCT",{"type":31,"name":38,"description":39,"armGroupLabels":40,"otherNames":17},"ETHOS 2.0","ETHOS 2.0, an artificial intelligence treatment planning system, will be utilized in an emulator to create SCRT plans to determine the feasibility of clinically significant ovarian dose reductions in-silico.",[24],[42],{"name":43,"affiliation":5,"role":44},"Michael Waters, M.D., Ph.D.","PRINCIPAL_INVESTIGATOR",[46],{"name":43,"role":47,"phone":48,"phoneExt":17,"email":49},"CONTACT","314-273-0275","m.r.waters@wustl.edu",[51],{"facility":5,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"RECRUITING","St Louis","Missouri","63110","United States","US",{"type":59,"coordinates":60},"Point",[61,62],-90.19789,38.62727,{"lat":62,"lon":61},[65,66,67,70,72,74,76,78,80,82,84,86],{"name":43,"role":47,"phone":48,"phoneExt":17,"email":49},{"name":43,"role":44,"phone":17,"phoneExt":17,"email":17},{"name":68,"role":69,"phone":17,"phoneExt":17,"email":17},"Daniel Hong, M.D.","SUB_INVESTIGATOR",{"name":71,"role":69,"phone":17,"phoneExt":17,"email":17},"Carl DeSelm, M.D., Ph.D.",{"name":73,"role":69,"phone":17,"phoneExt":17,"email":17},"Stephanie Markovina, M.D., Ph.D.",{"name":75,"role":69,"phone":17,"phoneExt":17,"email":17},"Jessika Contreras, M.D.",{"name":77,"role":69,"phone":17,"phoneExt":17,"email":17},"Kennan Omurtag, M.D.",{"name":79,"role":69,"phone":17,"phoneExt":17,"email":17},"Anup Shetty, M.D.",{"name":81,"role":69,"phone":17,"phoneExt":17,"email":17},"Eric Laugeman, M.S.",{"name":83,"role":69,"phone":17,"phoneExt":17,"email":17},"Robbie Beckert, M.S.",{"name":85,"role":69,"phone":17,"phoneExt":17,"email":17},"Kelly Kuechle, RTT",{"name":87,"role":69,"phone":17,"phoneExt":17,"email":17},"Esther Lu, Ph.D.",{"type":89,"investigatorFullName":17,"investigatorTitle":17,"investigatorAffiliation":17,"oldNameTitle":17,"oldOrganization":17},"SPONSOR",[91],{"name":92,"class":93},"Varian Medical Systems","INDUSTRY","100585592","ovarian-sparing-adaptive-radiotherapy-in-young-adult-women-100585592",false,"NCT06904365","Ovarian-Sparing Adaptive Radiotherapy in Young Adult Women","Ovarian-Sparing Adaptive Radiotherapy in Young Adult Women (OvAR-Y): an In-Silico Feasibility Trial","OvAR-Y","Inclusion Criteria:\n\n* Biologic female\n* Age between 18 and 50 years old (inclusive)\n* Clinically premenopausal (defined as having active, regular menstruation without vasomotor symptoms)\n* At least one of two ovaries readily visualized on diagnostic CT or MR imaging as confirmed by radiologist\n* Planning to receive radiation therapy (for any indication)\n* Ability to understand and willingness to sign an IRB-approved written informed consent document.\n\nExclusion Criteria:\n\n* Prior pelvic radiation\n* Prior cancer therapies that are known to impact ovarian function\n* Prior diagnosis of ovarian insufficiency\u002Ffailure or menopause\n* Clinically peri- or post-menopausal\n\n  * For patients \\> 45 years old, if there is a clinical history of vasomotor symptoms OR irregular periods, then the patient must be excluded.\n  * For patients ≤ 45 years old, if there is a history of vasomotor symptoms consistent with menopause OR irregular menstruation for ≥3 months OR recent changes in their menstrual cycle \\> 14 days, then the patient must be excluded.\n* Surgically removed or transposed ovaries\n* Pregnant and\u002For breastfeeding","FEMALE","18 Years","50 Years",{"count":106,"type":107},11,"ESTIMATED","OBSERVATIONAL","Female patients with early onset (\\\u003C50 years old) pelvic malignancies such as uterine and rectal cancers are rising in incidence, which often requires pelvic radiation; many of these patients are premenopausal and at a high risk of premature ovarian failure from radiotherapy. Premature ovarian failure carries significant cardiac, musculoskeletal, sexual, and psychosocial morbidity. Ovarian transposition carries variable success rates, is not readily accessible to the general population, and can still be at risk of clinically significant radiotherapy doses. There is an unmet need for innovative techniques to protect ovarian function.",[111,112,113,114,115,116,117,118,119,120,121,122],"Uterine Cancer","Rectal Cancer","Colon Cancer","Breast Cancer","Lung Cancer","Sarcoma","Cervix Cancer","Head and Neck Cancer","Anal Cancer","Liver Cancer","Gastric Cancer","Bladder Cancer",[124,125,126,127],"Young onset colorectal cancer","Early onset","Pre-menopausal","Ovarian sparing radiation","2026-08-28",{"date":130,"type":131},"2026-09-02","ACTUAL",{"date":133,"type":131},"2025-04-08",{"date":135,"type":107},"2026-10-31",{"name":5,"class":6},1]