Ovarian-Sparing Adaptive Radiotherapy in Young Adult Women

What this trial studies

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 in scope

• Uterine Cancer
• Rectal Cancer
• Colon Cancer
• Breast Cancer
• Lung Cancer
• Sarcoma
• Cervix Cancer
• Head and Neck Cancer

Interventions

• HyperSight cone beam computed tomography (CBCT) scan (Device) — HyperSight is a novel onboard imaging platform with a rapid-acquisition high-quality CBCT imager capable of acquiring images sufficient for simulation and treatment.
• ETHOS 2.0 (Device) — 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.

Who can join

Women only · Ages 18 Years to 50 Years

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

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Recruiting
• Study type: Observational
• Phase: N/A
• Start date: 2025-04-08
• Primary completion: 2026-06-30
• Last update posted: 2026-05-07
• First posted: 2025-04-01

Sponsor & contact

Lead sponsor: Washington University School of Medicine (Other)

Collaborators: Varian Medical Systems

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Incidence of ovarian visualization (Estimated to be 5 days)
  Defined as being able to delineate at least one ovary (if only one is visible, must be the same ovary) for ≥60% of CBCT sessions per patient.

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.