Ovarian-Sparing Adaptive Radiotherapy in Young Adult Women

Conditions

• Anal Cancer
• Bladder Cancer
• Breast Cancer
• Cervix Cancer
• Colon Cancer
• Gastric Cancer
• Head and Neck Cancer
• Liver Cancer
• Lung Cancer
• Rectal Cancer
• Sarcoma
• Uterine Cancer

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 50 Years

Healthy Volunteers

Not accepted

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.
• 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.

Study Details

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.

Key Dates

First listed

Apr 1, 2025

Start date

Apr 8, 2025

Status verified

Aug 2026

Primary completion

Oct 31, 2026

Completion

Oct 31, 2026

Study Design

Enrollment

11 participants (estimated)

Arms

• Arm: 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.

Primary Outcome Measure

Incidence of ovarian visualization [ Time Frame: Estimated to be 5 days ]

Central Contacts

• Michael Waters, M.D., Ph.D.
  314-273-0275
  [email protected]

Locations (1)

Find similar trials in St Louis, MO

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