Ovarian-Sparing Adaptive Radiotherapy in Young Adult Women (OvAR-Y)

August 28, 2026 updated by: Washington University School of Medicine

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

11

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Sub-Investigator:
          • Eric Laugeman, M.S.
        • Sub-Investigator:
          • Anup Shetty, M.D.
        • Sub-Investigator:
          • Jessika Contreras, M.D.
        • Sub-Investigator:
          • Esther Lu, Ph.D.
        • Sub-Investigator:
          • Carl DeSelm, M.D., Ph.D.
        • Sub-Investigator:
          • Stephanie Markovina, M.D., Ph.D.
        • Sub-Investigator:
          • Daniel Hong, M.D.
        • Sub-Investigator:
          • Kennan Omurtag, M.D.
        • Sub-Investigator:
          • Robbie Beckert, M.S.
        • Sub-Investigator:
          • Kelly Kuechle, RTT
        • Contact:
        • Principal Investigator:
          • Michael Waters, M.D., Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This study will enroll patients at Siteman Cancer Center at Washington University School of Medicine.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.
Other Names:
  • CBCT
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of ovarian visualization
Time Frame: 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.
Estimated to be 5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of dosimetrically sparing one or both ovaries from a functionally ablative radiation dose
Time Frame: Estimated to be 5 days
Defined as maintaining a cumulative >95% coverage of planned tumor volume (PTV) with 95% of the prescription dose (25 Gy/5 fx) while delivering no more 6 Gy to the ovaries per patient. If only one ovary can meet constraints it must be the same ovary over all fractions.
Estimated to be 5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

Varian Medical Systems

Investigators

  • Principal Investigator: Michael Waters, M.D., Ph.D., Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 8, 2025

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

October 31, 2026

Study Registration Dates

First Submitted

March 24, 2025

First Submitted That Met QC Criteria

March 24, 2025

First Posted (Actual)

April 1, 2025

Study Record Updates

Last Update Posted (Actual)

September 2, 2026

Last Update Submitted That Met QC Criteria

August 28, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202502088

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be shared if research proposal is submitted and approved by Principal Investigator.

IPD Sharing Access Criteria

Email Principal Investigator with research proposal.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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