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

Memorial Sloan Kettering Cancer Center (MSK)

Status: Enrolling

Conditions: Endometrial Cancer

Treatments: Diagnostic Test: Multiparametric Ultrasound Imaging; Other: The vaginal assessment score (VAS)

Study type: Interventional

Funder types: Other

Identifiers

NCT07318415

25-157

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Multiparametric Ultrasound Imaging (mpUS)

Experimental group

Description:

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.

Treatment:

Other: The vaginal assessment score (VAS)

Diagnostic Test: Multiparametric Ultrasound Imaging