Ovarian-Sparing Adaptive Radiotherapy in Young Adult Women

NCT ID: NCT06904365

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-04-08
• Study Completion Date: 2026-04-15

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; Sarcoma; Cervix Cancer; Head and Neck Cancer; Anal Cancer; Liver Cancer; Gastric Cancer; Bladder Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

HyperSight cone beam computed tomography (CBCT) scan

Intervention Type: 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

Intervention Type: 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.

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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

CBCT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Varian Medical Systems

INDUSTRY

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

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

Role: CONTACT

m.r.waters@wustl.edu

314-273-0275

Facility Contacts

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

Role: primary

m.r.waters@wustl.edu

314-273-0275

Related Links

http://siteman.wustl.edu

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Other Identifiers

202502088

Identifier Type: -

Identifier Source: org_study_id