Ovarian-Sparing Adaptive Radiotherapy in Young Adult Women

Last updated: April 9, 2025
Sponsor: Washington University School of Medicine
Overall Status: Active - Recruiting

Phase

N/A

Condition

Uterine Cancer

Sarcoma

Rectal Cancer

Treatment

ETHOS 2.0

HyperSight cone beam computed tomography (CBCT) scan

Clinical Study ID

NCT06904365
202502088
  • Ages 18-50
  • Female

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Biologic female

  • Age between 18 and 50 years old (inclusive)

  • Clinically premenopausal (defined as having active, regular menstruation withoutvasomotor symptoms)

  • At least one of two ovaries readily visualized on diagnostic CT or MR imaging asconfirmed by radiologist

  • Planning to receive radiation therapy (for any indication)

  • Ability to understand and willingness to sign an IRB-approved written informedconsent document.

Exclusion

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 vasomotorsymptoms OR irregular periods, then the patient must be excluded.

  • For patients ≤ 45 years old, if there is a history of vasomotor symptomsconsistent with menopause OR irregular menstruation for ≥3 months OR recentchanges in their menstrual cycle > 14 days, then the patient must be excluded.

  • Surgically removed or transposed ovaries

  • Pregnant and/or breastfeeding

Study Design

Total Participants: 10
Treatment Group(s): 2
Primary Treatment: ETHOS 2.0
Phase:
Study Start date:
April 08, 2025
Estimated Completion Date:
April 15, 2026

Connect with a study center

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

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