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NCT Number: NCT07318415

A Study of Multiparametric Ultrasound Imaging (mpUS) for People With Endometrial Cancer

The researchers are doing this study to see how well multiparametric ultrasound (mpUS) imaging can evaluate vaginal tissue before and after IVRT. IVRT is routinely used to treat endometrial cancer but can cause damage to the vaginal tissue (vaginal toxicity). Side effects of vaginal toxicity can include vaginal dryness, itching, soreness, discharge, narrowing or shortening of the vagina (stenosis), and vaginal fibrosis (hardening), which can affect sexual function. The researchers will also look at whether participants are able to complete (tolerate) all mpUS imaging for this study.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Memorial Sloan Kettering at Basking Ridge (Consent Only), Basking Ridge, New Jersey, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients must be diagnosed with a primary endometrial carcinoma. The following histologic subtypes are eligible for inclusion: endometrioid, serious, clear cell, dedifferentiated/undifferentiated, mixed epithelial, adenocarcinoma not otherwise specified, and carcinosarcoma
  • Initial surgical treatment must have included hysterectomy, bilateral salpingo-oophorectomy, and pelvic lymph node assessment with either sentinel lymph node mapping/sampling or pelvic lymph node dissection. Surgical assessment of the para-aortic lymph nodes is not required
  • Patients must have had a complete surgical resection with negative margins and no residual gross disease after surgery
  • Patients must have FIGO (2009) stage I-II disease (per surgical staging)
  • Age ≥ 18 years
  • Patients must be able to start radiotherapy within 12 weeks from date of surgery

Exclusion criteria

  • Patients receiving chemotherapy or hormonal therapy
  • A prior or concurrent malignancy whose natural history or treatment would interfere with the toxicity or efficacy assessment of IVRT
  • Prior pelvic radiotherapy
  • Active genitourinary infection requiring antibiotics, except for uncomplicated urinary tract infection
  • History of active inflammatory bowel disease requiring treatment, including Crohn's disease and ulcerative colitis
  • Concurrent psychiatric or medical condition or disease which, per investigator judgement, would make them unsuitable candidates for study enrollment

Treatment and study plan

Multiparametric Ultrasound Imaging

Diagnostic Test

multiparametric ultrasound (mpUS) imaging right before IVRT, right after the last IVRT, and at 3, 6 and 12 months after IVRT

The vaginal assessment score (VAS)

Other

The vaginal assessment score (VAS) is a four-item measure that is administered to the patient to quantify and rate (none, mild, moderate, or severe) their perception of dryness, soreness, irritation, and pain (dyspareunia or painfulness to touch with external stimulation).

Primary outcomes

  1. feasibility of B-mode ultrasound imaging

    Time frame: 1 year

    B-mode feasibility is defined as the ability to visualize/quantify vaginal wall thickness and echogenicity at baseline and immediately following the last IVRT treatment in 6 out of 10 patients.

Study contacts

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

Kaled Alektiar, MD

CONTACT

[email protected]

212-639-7981

Mark Burgess, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

Quantitative Assessment of Vaginal Tissue Response to Intravaginal Brachytherapy With Multiparametric Ultrasound Imaging (mpUS)

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 6, 2026
Registry last updated
Jan 6, 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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