Ovarian-Sparing Adaptive Radiotherapy in Young Adult Women (OvAR-Y): an In-Silico Feasibility Trial

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: f
View:

• Biologic female

• Age between 18 and 50 years old (inclusive)

• Clinically premenopausal (defined as having active, regular menstruation without vasomotor symptoms)

• At least one of two ovaries readily visualized on diagnostic CT or MR imaging as confirmed by radiologist

• Planning to receive radiation therapy (for any indication)

• Ability to understand and willingness to sign an IRB-approved written informed consent document.

Locations
United States
Missouri
Washington University School of Medicine
RECRUITING
St Louis
Contact Information
Primary
Michael Waters, M.D., Ph.D.
m.r.waters@wustl.edu
314-273-0275
Time Frame
Start Date: 2025-04-08
Estimated Completion Date: 2026-04-15
Participants
Target number of participants: 10
Treatments
Ovarian-Sparing Adaptive Radiotherapy
A 25 Gy / 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 / 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.
Sponsors
Leads: Washington University School of Medicine
Collaborators: Varian Medical Systems

This content was sourced from clinicaltrials.gov