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OvAR-YNCT06904365

Ovarian-Sparing Adaptive Radiotherapy in Young Adult Women

StatusCompleted
PhaseNot specified
Primary completion
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Record History

All 10 versions: 10 with changes below. See every version on ClinicalTrials.gov ↗

  1. Minor Trial completed Show 4 more changesShow less
    • Primary and study completion dates changed from estimate of Oct 31, 2026 to Oct 14, 2026
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Site details revised
  2. Minor Sponsor refiled this as recruiting (was completed)
    • Enrollment target: 10 to 11
    • Primary and study completion dates: Aug 17, 2026 to Oct 31, 2026
    • Site details revised
    v9
  3. Minor Trial completed
    • Primary and study completion dates changed from estimate of Aug 31, 2026 to Aug 17, 2026
    v8
  4. Minor Primary and study completion pushed from Jul 10, 2026 to Aug 31, 2026v7
  5. Minor Primary and study completion pushed from May 31, 2026 to Jul 10, 2026v6
  6. Minor Trial status changed: Recruiting → Active, Not Recruiting
    • Primary and study completion moved earlier from Jun 30, 2026 to May 31, 2026
    • Site details revised
    v5
  7. Minor Primary and study completion dates: Apr 15, 2026 to Jun 30, 2026v4
  8. Minor Site contact updatedv3
  9. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Apr 1, 2025 to Apr 8, 2025
    • Site details revised
    v2
  10. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Incidence of ovarian visualization
Timeframe: Estimated to be 5 days

Secondary (1)

Incidence of dosimetrically sparing one or both ovaries from a functionally ablative radiation dose

Arms and interventions

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.

Devices: HyperSight cone beam computed tomography (CBCT) scan, ETHOS 2.0

Sites

1 site in 1 country

  • Washington University School of MedicineSt Louis, Missouri, United States