A Study of Multiparametric Ultrasound Imaging (mpUS) for People With Endometrial Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Multiparametric Ultrasound Imaging, The vaginal assessment score (VAS).
- Who it may be relevant to
- Registry conditions: Endometrial Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Quantitative Assessment of Vaginal Tissue Response to Intravaginal Brachytherapy With Multiparametric Ultrasound Imaging (mpUS)
Overview
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.
Interventions
- Diagnostic test Multiparametric Ultrasound Imaging
multiparametric ultrasound (mpUS) imaging right before IVRT, right after the last IVRT, and at 3, 6 and 12 months after IVRT - Other 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 measures
- feasibility of B-mode ultrasound imaging [Time frame: 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 7 centers
- Memorial Sloan Kettering at Basking Ridge (Consent Only) — Basking Ridge
- Memorial Sloan Kettering Monmouth (Consent Only) — Middletown
- Memorial Sloan Kettering Bergen (Consent Only) — Montvale
- Memorial Sloan Kettering Suffolk - Commack (Consent Only) — Commack
- Memorial Sloan Kettering Westchester (Consent Only) — Harrison
- Memorial Sloan Kettering Cancer Center — New York
- Memorial Sloan Kettering Nassau (Consent Only) — Uniondale
Identifiers
NCT: NCT07318415 · 25-157