RecruitingNCT06904365

Ovarian-Sparing Adaptive Radiotherapy in Young Adult Women

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

Sponsor

Washington University School of Medicine

Enrollment

10 participants

Start Date

Apr 8, 2025

Study Type

OBSERVATIONAL

Conditions

Breast Cancer Liver Cancer Gastric Cancer Sarcoma Lung Cancer Head and Neck Cancer Colon Cancer Rectal Cancer Bladder Cancer Uterine Cancer Anal Cancer Cervix Cancer

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

Sex: FEMALEMin Age: 18 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study is developing a smarter radiation therapy approach that adjusts the treatment to better protect the ovaries in young women, helping to preserve fertility and hormonal health during cancer treatment. **You may be eligible if...** - You are a biological female between 18 and 50 years old - You are still having regular periods (premenopausal) - You have at least one ovary that is visible on a CT or MRI scan - You are planning to receive radiation therapy for any medical condition **You may NOT be eligible if...** - You have previously had pelvic radiation - You have had prior cancer therapies known to harm ovarian function - You have been diagnosed with ovarian insufficiency or early menopause - You are peri- or post-menopausal (or showing symptoms like hot flashes or irregular periods, especially if over 45) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEHyperSight 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.

DEVICEETHOS 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.