Ovarian-Sparing Adaptive Radiotherapy in Young Adult Women
Recruiting · NCT06904365 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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 it is running
2 locations listed across 1 US state.
- Washington University School of Medicine - St Louis, Missouri, United States
- Washington University School of Medicine - St Louis, Missouri, United States