Ovarian-Sparing Adaptive Radiotherapy in Young Adult Women

NCT06904365 | Recruiting FDA Device

• 1 other identifier: 202502088
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Incidence of ovarian visualization

  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 Outcomes (1)

• Incidence of dosimetrically sparing one or both ovaries from a functionally ablative radiation dose

  Estimated to be 5 days

Study Arms (1)

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; Device: ETHOS 2.0

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.

Also known as: CBCT

Ovarian-Sparing Adaptive Radiotherapy

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.

Ovarian-Sparing Adaptive Radiotherapy

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Varian Medical Systems: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Related Links

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

MeSH Terms

Conditions

Uterine Neoplasms; Rectal Neoplasms; Colonic Neoplasms; Breast Neoplasms; Lung Neoplasms; Sarcoma; Uterine Cervical Neoplasms; Head and Neck Neoplasms; Anus Neoplasms; Liver Neoplasms; Stomach Neoplasms; Urinary Bladder Neoplasms

Interventions

Radionuclide Imaging

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Colonic Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Uterine Cervical Diseases; Anus Diseases; Liver Diseases; Stomach Diseases; Urologic Neoplasms; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Radioisotope

Study Officials

• Michael Waters, M.D., Ph.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: April 1, 2025
• Study Start: April 8, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Access Criteria: Email Principal Investigator with research proposal.

Locations

US (1)