Recruiting

mpUS

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT07318415

Conditions

Endometrial Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Multiparametric Ultrasound Imaging

The vaginal assessment score (VAS)

Study Details

Brief summary:

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.

Conditions

Endometrial Cancer

Study ID

NCT07318415

Start date

Dec 11, 2025

Status verified date

Dec, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Multiparametric Ultrasound Imaging (mpUS)

All participants in this study will receive standard intravaginal brachytherapy (IVRT) and multiparametric ultrasound (mpUS) imaging right before IVRT, right after the last IVRT, and at 3, 6 and 12 months after IVRT.

Interventions

Multiparametric Ultrasound Imaging

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)

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 outcome measure

  • feasibility of B-mode ultrasound imaging [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Kaled Alektiar, MD

212-639-7981alektiak@mskcc.org

Mark Burgess, MD

burgesm1@mskcc.org

Locations

Memorial Sloan Kettering at Basking Ridge (Consent Only)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Kalad Alektiar, MD

212-639-7981

Memorial Sloan Kettering Monmouth (Consent Only)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Kaled Alektiar, MD

212-639-7981

Memorial Sloan Kettering Bergen (Consent Only)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Kaled Alektiar, MD

212-639-7981

Memorial Sloan Kettering Suffolk - Commack (Consent Only)

Recruiting

Commack, New York, United States, 11725

Contacts

Kaled Alektiar, MD

212-639-7981

Memorial Sloan Kettering Westchester (Consent Only)

Recruiting

Harrison, New York, United States, 10604

Contacts

Kaled Alektiar, MD

212-639-7981

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Kaled Alektiar, MD

212-639-7981

Mark Burgess, PhD

burgesm1@mskcc.org

Memorial Sloan Kettering Nassau (Consent Only)

Recruiting

Uniondale, New York, United States, 11553

Contacts

Kaled Alektiar, MD

212-639-7981

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Jan 6, 2026

Last verified

Dec, 2025

Keywords

  • stage I-II endometrial carcinoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-01-06.