Ovarian-Sparing Adaptive Radiotherapy in Young Adult Women
NCT06904365 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 10
Last updated 2026-05-18
Summary
Female patients with early onset (\<50 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.
Conditions
Interventions
- 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.
- DEVICE
-
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.
Sponsors & Collaborators
-
Varian Medical Systems
collaborator INDUSTRY -
Washington University School of Medicine
lead OTHER
Principal Investigators
-
Michael Waters, M.D., Ph.D. · Washington University School of Medicine
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-04-08
- Primary Completion
- 2026-05-31
- Completion
- 2026-05-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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