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

The Washington University

Status: Enrolling

Conditions: Anal Cancer; Breast Cancer; Uterine Cancer; Colon Cancer; Lung Cancer; Liver Cancer; Bladder Cancer; Sarcoma; Gastric Cancer; Head and Neck Cancer; Cervix Cancer; Rectal Cancer

Treatments: Device: ETHOS 2.0; Device: HyperSight cone beam computed tomography (CBCT) scan

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06904365

202502088

Details and patient eligibility

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.

Enrollment: 10 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

10 participants in 1 patient group

Ovarian-Sparing Adaptive Radiotherapy

Description:

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.

Treatment:

Device: HyperSight cone beam computed tomography (CBCT) scan

Device: ETHOS 2.0