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RECRUITING
NCT06518174
NA

A Novel Imaging Modality to Evaluate Radiation-Induced Uterine Injury

Sponsor: University of Colorado, Denver

View on ClinicalTrials.gov

Summary

The goal of this pilot study is to assess the ability of a new imaging modality, shear-wave-elastography (SWE) and magnetic resonance imaging (MRI) to identify radiation-induced uterine injury (RIUI). The investigator will recruit female patients treated before 40 years with pelvic radiation (PRT) at least 12 months prior to study initiation.

Key Details

Gender

FEMALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

22

Start Date

2025-02-25

Completion Date

2027-03

Last Updated

2025-09-23

Healthy Volunteers

No

Conditions

Interventions

DIAGNOSTIC_TEST

MRI, SWE, and US evaluation

We will perform SWE and MRI sampling of the uterus from fundus to lower uterine segment with at least two points each from the upper, mid, and lower thirds of the uterus. SWE and MRI will be performed at time of study recruitment. US procedures will be transabdominal. When possible, we will also collect transvaginal US. MRI images will also be sampled from existing pretreatment studies performed as standard of care. All images will be evaluated for the presence and degree of fibrosis. We will compare SWE and MRI post-treatment. We will also compare pre-and post-treatment MRI. We will perform US and estimate uterine volumes and arterial resistance. Use descriptive statistics to compare values to age-matched controls

Locations (1)

University of Colorado

Aurora, Colorado, United States