Multiparametric ultrasound to examine vaginal tissue in people with endometrial cancer

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

We will test whether multiparametric ultrasound can spot changes in vaginal tissue before and after intravaginal radiotherapy in people treated for stage I–II endometrial cancer.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Memorial Sloan Kettering Cancer Center (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 7 sites (Basking Ridge, New Jersey and 6 other locations)
• Trial ID: NCT07318415 on ClinicalTrials.gov

What this trial studies

Participants will undergo multiparametric ultrasound (mpUS) imaging of the vagina before and after intravaginal radiotherapy (IVRT) to document tissue changes. Imaging results will be compared with a standardized vaginal assessment score (VAS) and clinical findings to characterize vaginal toxicity such as dryness, stenosis, and fibrosis. The study will also record whether participants can tolerate all mpUS procedures to determine feasibility. Eligible patients are adults with surgically staged FIGO 2009 stage I–II endometrial carcinoma who had complete resection and are scheduled to start IVRT within 12 weeks of surgery.

Who should consider this trial

Good fit: Adults (≥18) with FIGO 2009 stage I–II endometrial carcinoma who had hysterectomy with bilateral salpingo-oophorectomy, pelvic lymph node assessment, negative margins, and who can start intravaginal radiotherapy within 12 weeks of surgery are ideal candidates.

Not a fit: Patients receiving chemotherapy or hormonal therapy, those with residual or more advanced disease, or with a concurrent/previous malignancy are excluded and unlikely to benefit from this imaging-focused protocol.

Why it matters

Potential benefit: If successful, mpUS could offer a noninvasive way to detect and monitor IVRT-related vaginal damage earlier and guide interventions to preserve sexual function and quality of life.

How similar studies have performed: Related pelvic imaging techniques have been used to study radiotherapy effects, but using mpUS specifically to detect IVRT-induced vaginal toxicity is a relatively novel approach with limited prior data.

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

Where this trial is running

Basking Ridge, New Jersey and 6 other locations

• Memorial Sloan Kettering at Basking Ridge (Consent Only) — Basking Ridge, New Jersey, United States (Recruiting)
• Memorial Sloan Kettering Monmouth (Consent Only) — Middletown, New Jersey, United States (Recruiting)
• Memorial Sloan Kettering Bergen (Consent Only) — Montvale, New Jersey, United States (Recruiting)
• Memorial Sloan Kettering Suffolk - Commack (Consent Only) — Commack, New York, United States (Recruiting)
• Memorial Sloan Kettering Westchester (Consent Only) — Harrison, New York, United States (Recruiting)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
• Memorial Sloan Kettering Nassau (Consent Only) — Uniondale, New York, United States (Recruiting)

Study contacts

• Principal investigator: Kaled Alektiar, MD — Memorial Sloan Kettering Cancer Center
• Study coordinator: Kaled Alektiar, MD

Conditions Endometrial Cancer; stage I-II endometrial carcinoma