RECRUITINGOBSERVATIONAL

Ovarian-Sparing Adaptive Radiotherapy in Young Adult Women

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form document. Who Should NOT Join This Trial: - Prior pelvic radiation - Prior cancer therapies that are known to impact ovarian function - Prior diagnosis of ovarian insufficiency/failure or menopause - Clinically peri- or post-menopausal - For patients \> 45 years old, if there is a clinical history of vasomotor symptoms OR irregular periods, then the patient must be excluded. - 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. - Surgically removed or transposed ovaries - Pregnant and/or breastfeeding Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * 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. Exclusion Criteria: * Prior pelvic radiation * Prior cancer therapies that are known to impact ovarian function * Prior diagnosis of ovarian insufficiency/failure or menopause * Clinically peri- or post-menopausal * For patients \> 45 years old, if there is a clinical history of vasomotor symptoms OR irregular periods, then the patient must be excluded. * 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. * Surgically removed or transposed ovaries * Pregnant and/or breastfeeding

Treatments Being Tested

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.

Locations (1)

Washington University School of Medicine

St Louis, Missouri, United States