NCT06904365

Ovarian-Sparing Adaptive Radiotherapy in Young Adult Women

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 10 (estimated)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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

• 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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-04-08
• Primary completion: 2026-04-15
• Completion: 2026-04-15
• First posted: 2025-04-01
• Last updated: 2025-09-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study