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

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Other, Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
New Jersey
Memorial Sloan Kettering at Basking Ridge (Consent Only)
RECRUITING
Basking Ridge
Memorial Sloan Kettering Monmouth (Consent Only)
RECRUITING
Middletown
Memorial Sloan Kettering Bergen (Consent Only)
RECRUITING
Montvale
New York
Memorial Sloan Kettering Suffolk - Commack (Consent Only)
RECRUITING
Commack
Memorial Sloan Kettering Westchester (Consent Only)
RECRUITING
Harrison
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Memorial Sloan Kettering Nassau (Consent Only)
RECRUITING
Uniondale
Contact Information
Primary
Kaled Alektiar, MD
alektiak@mskcc.org
212-639-7981
Backup
Mark Burgess, MD
burgesm1@mskcc.org
Time Frame
Start Date: 2025-12-11
Estimated Completion Date: 2026-12
Participants
Target number of participants: 10
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Memorial Sloan Kettering Cancer Center

This content was sourced from clinicaltrials.gov