RecruitingNot ApplicableNCT07318415

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

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

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

10 participants

Start Date

Dec 11, 2025

Study Type

INTERVENTIONAL

Conditions

Endometrial Cancer

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria5

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 Criteria6

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

Interventions

DIAGNOSTIC_TESTMultiparametric Ultrasound Imaging

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

OTHERThe 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).