Clinical trial · Interventional
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Multiparametric Ultrasound Imaging | Diagnostic Test | — | UNRESOLVED |
| The vaginal assessment score (VAS) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Multiparametric Ultrasound Imaging (mpUS)
- 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.
- interventionNames
- Diagnostic Test: Multiparametric Ultrasound Imaging
- Other: The vaginal assessment score (VAS)
Primary outcomes (1)
- measure
- feasibility of B-mode ultrasound imaging
- timeFrame
- 1 year
- description
- B-mode feasibility is defined as the ability to visualize/quantify vaginal wall thickness and echogenicity at baseline and immediately following the last IVRT treatment in 6 out of 10 patients.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
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