Ovarian-sparing radiation for young women with pelvic cancers
Ovarian-Sparing Adaptive Radiotherapy in Young Adult Women (OvAR-Y): an In-Silico Feasibility Trial
Washington University School of Medicine · NCT06904365
This study is testing new radiation techniques to see if they can help young women with pelvic cancers keep their ovaries healthy while still getting the treatment they need.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Washington University School of Medicine (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (St Louis, Missouri) |
| Trial ID | NCT06904365 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on young adult women under 50 years old who are diagnosed with pelvic malignancies such as uterine and rectal cancers. It aims to explore innovative techniques for ovarian-sparing adaptive radiotherapy to minimize the risk of premature ovarian failure, which can lead to significant health issues. The study will utilize advanced imaging techniques like HyperSight cone beam computed tomography (CBCT) and ETHOS 2.0 to assess the effectiveness of these approaches. Participants will be premenopausal women who are planning to receive radiation therapy and meet specific eligibility criteria.
Who should consider this trial
Good fit: Ideal candidates are biologically female patients aged 18 to 50 who are clinically premenopausal and planning to receive radiation therapy.
Not a fit: Patients who have previously undergone pelvic radiation or have a history of ovarian insufficiency or menopause may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help preserve ovarian function in young women undergoing radiation therapy, reducing the risk of associated health complications.
How similar studies have performed: While there is ongoing research in ovarian-sparing techniques, this specific approach appears to be novel and untested in this context.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
St Louis, Missouri
- Washington University School of Medicine — St Louis, Missouri, United States (RECRUITING)
Study contacts
- Principal investigator: Michael Waters, M.D., Ph.D. — Washington University School of Medicine
- Study coordinator: Michael Waters, M.D., Ph.D.
- Email: m.r.waters@wustl.edu
- Phone: 314-273-0275
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Uterine Cancer, Rectal Cancer, Colon Cancer, Breast Cancer, Lung Cancer, Sarcoma, Cervix Cancer, Head and Neck Cancer