A Novel Imaging Modality to Evaluate Radiation-Induced Uterine Injury

NCT06518174 | Terminated DMC FDA Device

• 1 other identifier: 21-5074.cc
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Uterine Injury

Keywords

Uterine Injury; Radiation

Outcome Measures

Primary Outcomes (3)

• SWE feasibility

  SWE will be considered feasible if at least 85% (e.g., ≥15/17) of all patients achieve the diagnosability criteria, defined as having at least 1 of 6 locations with IQR/M ≤ 30%. The IQR/M and the number of patients who achieved diagnosability will be descriptively characterized.

  Up to six months

• Compare the degree of fibrosis according to SWE and MRI parameters across treatment groups

  Since fibrosis thresholds have not been thoroughly established for SWE tissue stiffness nor MRI parameters, continuous SWE tissue stiffness (kPA) will be compared separately to each MRI parameter: uterus size, junctional anatomy, endometrial thickness, cervical length, myometrial thickness, T2 signal, and enhanced features.

  Up to six months

• Evaluate the correlation between MRI images collected at pretreatment and after recruitment, using repeated measures correlation.

  Descriptive statistics and previously described figures will be similarly used to characterize the change in each MRI parameter between the pre-treatment and post-treatment timepoints. Additionally, linear mixed effects regression models will be performed separately with each MRI parameter. The predictors will include pre- and post- treatment time points and treatment group. If appropriate, radiation dose will be included in the model as well, where the radiation dose will be assigned as 0 for the control patients. Contrast statements will be used to assess the change in each outcome comparing treatment groups and the radiation doses effect.

  Up to six months

Secondary Outcomes (1)

• Characterize uterine parameters after PRT

  Up to six months

Study Arms (2)

Cases undergone PRT

ACTIVE COMPARATOR

Patients (or their legal guardians) who opt for participating in this pilot study will be consented and enrolled in the study. Patients will then be scheduled for a single study visit at the University of Colorado Hospital (UCH) that includes: 1. Pregnancy test 2. Pelvic MRI without and with contrast (if patient consents to contrast) 3. Transabdominal pelvic ultrasound using standard B-mode and Doppler US, SWE 4. Optional transvaginal ultrasound using standard B-mode and Doppler US, SWE

Diagnostic Test: MRI, SWE, and US evaluation

Controls

SHAM COMPARATOR

Controls (or their legal guardians) who opt for participating in this pilot study will be consented and enrolled in the study. Patients will then be scheduled for a single study visit at the University of Colorado Hospital (UCH) that includes: 1. Pregnancy test 2. Pelvic MRI without and with contrast (if patient consents to contrast) 3. Transabdominal pelvic ultrasound using standard B-mode and Doppler US, SWE 4. Optional transvaginal ultrasound using standard B-mode and Doppler US, SWE

Diagnostic Test: MRI, SWE, and US evaluation

Interventions

MRI, SWE, and US evaluation DIAGNOSTIC_TEST

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

Cases undergone PRT; Controls

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female
• Less than 40 years old "at the time of pelvic radiation"
• ≥ 18 and \< 45 years of age "at time of enrollment"
• Treated with PRT at UCH
• Pelvic MRI taken before the pelvic radiation

You may not qualify if:

• Patients who underwent hysterectomy for treatment of a primary gynecologic malignancy
• Patients that are currently pregnant

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Interventions

Magnetic Resonance Imaging

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Sarah Milgrom, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 24, 2024
• Study Start: February 25, 2025
• Primary Completion: May 31, 2026
• Study Completion: June 3, 2026
• Last Updated: June 8, 2026

Record last verified: 2026-06

Locations

US (1)