Recruiting

Ovarian-Sparing Radiotherapy

Sponsor:

Washington University School of Medicine

Code:

NCT06904365

Conditions

Uterine Cancer

Rectal Cancer

Colon Cancer

Breast Cancer

Lung Cancer

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

HyperSight cone beam computed tomography (CBCT) scan

ETHOS 2.0

Study Details

Brief 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

Study ID

NCT06904365

Start date

Apr 8, 2025

Status verified date

Aug, 2026

Completion date

Oct 31, 2026

Anticipated

Primary completion date

Oct 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

11 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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.

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.

Primary outcome measure

  • Incidence of ovarian visualization [ Time Frame: Estimated to be 5 days ]

Central Contacts and Locations

Central contacts

Michael Waters, M.D., Ph.D.

314-273-0275m.r.waters@wustl.edu

Locations

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Michael Waters, M.D., Ph.D.

314-273-0275m.r.waters@wustl.edu

Principal Investigator:

Michael Waters, M.D., Ph.D.

More Information

Sponsor

Washington University School of Medicine

Last update posted

Sep 2, 2026

Last verified

Aug, 2026

Keywords

  • Young onset colorectal cancer
  • Early onset
  • Pre-menopausal
  • Ovarian sparing radiation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-09-02.