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Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 50 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

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

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
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
    HyperSight is a novel onboard imaging platform with a rapid-acquisition high-quality CBCT imager capable of acquiring images sufficient for simulation and treatment.
    Other names:
    • CBCT
  • Device: ETHOS 2.0
    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.

Recruiting Locations

Washington University in St. Louis and nearby locations

Washington University School of Medicine
St Louis 4407066, Missouri 4398678 63110
Contact:
Michael Waters, M.D., Ph.D.
314-273-0275
m.r.waters@wustl.edu

More Details

NCT ID
NCT06904365
Status
Recruiting
Sponsor
Washington University School of Medicine

Study Contact

Michael Waters, M.D., Ph.D.
314-273-0275
m.r.waters@wustl.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.