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NCT Number: NCT06904365

Ovarian-Sparing Adaptive Radiotherapy in Young Adult Women

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.

Recruiting

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Key information

Conditions

Uterine Cancer Anal Cancer Anus Diseases Anus Neoplasms Bladder Cancer Breast Cancer Breast Diseases Breast Neoplasms Cervix Cancer Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastric Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Head and Neck Cancer Head and Neck Neoplasms Intestinal Diseases Intestinal Neoplasms Liver Cancer Liver Diseases Liver Neoplasms Lung Cancer Lung Diseases Lung Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective and Soft Tissue Rectal Cancer Rectal Diseases Rectal Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Sarcoma Skin Diseases Skin and Connective Tissue Diseases Stomach Diseases Stomach Neoplasms Thoracic Neoplasms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location status: Recruiting

Location contact

Anup Shetty, M.D.

SUB_INVESTIGATOR

Carl DeSelm, M.D., Ph.D.

SUB_INVESTIGATOR

Daniel Hong, M.D.

SUB_INVESTIGATOR

Eric Laugeman, M.S.

SUB_INVESTIGATOR

Esther Lu, Ph.D.

SUB_INVESTIGATOR

Jessika Contreras, M.D.

SUB_INVESTIGATOR

Kelly Kuechle, RTT

SUB_INVESTIGATOR

Kennan Omurtag, M.D.

SUB_INVESTIGATOR

Michael Waters, M.D., Ph.D.

CONTACT

[email protected]

314-273-0275

Michael Waters, M.D., Ph.D.

PRINCIPAL_INVESTIGATOR

Robbie Beckert, M.S.

SUB_INVESTIGATOR

Stephanie Markovina, M.D., Ph.D.

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: CBCT

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.

Primary outcomes

  1. Incidence of ovarian visualization

    Time frame: Estimated to be 5 days

    Defined as being able to delineate at least one ovary (if only one is visible, must be the same ovary) for ≥60% of CBCT sessions per patient.

Secondary outcomes

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

    Time frame: Estimated to be 5 days

    Defined as maintaining a cumulative >95% coverage of planned tumor volume (PTV) with 95% of the prescription dose (25 Gy/5 fx) while delivering no more 6 Gy to the ovaries per patient. If only one ovary can meet constraints it must be the same ovary over all fractions.

Study contacts

Contact information is provided by the study sponsor or research team.

Michael Waters, M.D., Ph.D.

CONTACT

[email protected]

314-273-0275

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Varian Medical Systems

Registry information

Official study title

Ovarian-Sparing Adaptive Radiotherapy in Young Adult Women (OvAR-Y): an In-Silico Feasibility Trial

Acronym: OvAR-Y

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 1, 2025
Registry last updated
Sep 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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