NCT07318415

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
7mo left

Started Dec 2025

Geographic Reach
1 country

7 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress42%
Dec 2025Dec 2026

Study Start

First participant enrolled

December 11, 2025

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

December 23, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 6, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

January 6, 2026

Status Verified

December 1, 2025

Enrollment Period

12 months

First QC Date

December 23, 2025

Last Update Submit

December 23, 2025

Conditions

Endometrial Cancer

Keywords

stage I-II endometrial carcinoma

Outcome Measures

Primary Outcomes (1)

  • feasibility of B-mode ultrasound imaging

    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.

    1 year

Study Arms (1)

Multiparametric Ultrasound Imaging (mpUS)

EXPERIMENTAL

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.

Diagnostic Test: Multiparametric Ultrasound ImagingOther: The vaginal assessment score (VAS)

Interventions

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).

Multiparametric Ultrasound Imaging (mpUS)
Multiparametric Ultrasound ImagingDIAGNOSTIC_TEST

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

Multiparametric Ultrasound Imaging (mpUS)

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsEndometrial Cancer
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Memorial Sloan Kettering at Basking Ridge (Consent Only)

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Memorial Sloan Kettering Monmouth (Consent Only)

Middletown, New Jersey, 07748, United States

RECRUITING

Memorial Sloan Kettering Bergen (Consent Only)

Montvale, New Jersey, 07645, United States

RECRUITING

Memorial Sloan Kettering Suffolk - Commack (Consent Only)

Commack, New York, 11725, United States

RECRUITING

Memorial Sloan Kettering Westchester (Consent Only)

Harrison, New York, 10604, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Memorial Sloan Kettering Nassau (Consent Only)

Uniondale, New York, 11553, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Kaled Alektiar, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kaled Alektiar, MD

CONTACT

212-639-7981alektiak@mskcc.org

Mark Burgess, MD

CONTACT

burgesm1@mskcc.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
This will be a prospective, single center clinical study with 10 patients with endometrial cancer to test the feasibility of using mpUS to characterize the vaginal tissue response to IVRT.
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2025

First Posted

January 6, 2026

Study Start

December 11, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

January 6, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Locations

US(7)