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

NCT ID: NCT07318415

Last Updated: 2026-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-11

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Endometrial Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

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.

Study Groups

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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.

Group Type EXPERIMENTAL

Multiparametric Ultrasound Imaging

Intervention Type 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)

Intervention Type 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).

Interventions

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Multiparametric Ultrasound Imaging

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

Intervention Type DIAGNOSTIC_TEST

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).

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kaled Alektiar, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Memorial Sloan Kettering at Basking Ridge (Consent Only)

Basking Ridge, New Jersey, United States

Site Status RECRUITING

Memorial Sloan Kettering Monmouth (Consent Only)

Middletown, New Jersey, United States

Site Status RECRUITING

Memorial Sloan Kettering Bergen (Consent Only)

Montvale, New Jersey, United States

Site Status RECRUITING

Memorial Sloan Kettering Suffolk - Commack (Consent Only)

Commack, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Westchester (Consent Only)

Harrison, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Nassau (Consent Only)

Uniondale, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kaled Alektiar, MD

Role: CONTACT

212-639-7981

Mark Burgess, MD

Role: CONTACT

Facility Contacts

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Kalad Alektiar, MD

Role: primary

212-639-7981

Kaled Alektiar, MD

Role: primary

212-639-7981

Kaled Alektiar, MD

Role: primary

212-639-7981

Kaled Alektiar, MD

Role: primary

212-639-7981

Kaled Alektiar, MD

Role: primary

212-639-7981

Kaled Alektiar, MD

Role: primary

212-639-7981

Mark Burgess, PhD

Role: backup

Kaled Alektiar, MD

Role: primary

212-639-7981

Related Links

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https://www.mskcc.org

Memorial Sloan Kettering Cancer Center

Other Identifiers

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25-157

Identifier Type: -

Identifier Source: org_study_id

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