A Novel Imaging Modality to Evaluate Radiation-Induced Uterine Injury

NCT ID: NCT06518174

Last Updated: 2025-09-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-25
• Study Completion Date: 2027-03-31

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.

Detailed Description

The investigator will recruit female patients treated before 40 years with pelvic radiation (PRT) at least 12 months prior to study initiation.12 months is selected to increase the occurrence of uterine fibrosis. The investigator will perform transabdominal standard B-mode and Doppler US, SWE and pelvic MRI and characterize uterine parameters. The B-mode and Doppler US will be referred to collectively as US. This will provide essential information to design an intervention trial of a novel therapeutic approach to the treatment of radiation-induced uterine damage. The overall objective of the study will be achieved through the following specific aims:

Aim 1: Assess the feasibility of SWE and pelvic MRI to identify and characterize uterine fibrosis. Hypothesis: A grid map sampling of the uterus will indicate feasibility of SWE and pelvic MRI to detect and characterize uterine fibrosis.

Approach: SWE and MRI will be performed at time of study recruitment. US procedures will be transabdominal. When possible, and with participant consent, transvaginal US will also be performed. MRI images will also be sampled from existing pretreatment studies performed as standard of care.

Perform SWE and MRI sampling of the uterus from fundus to lower uterine segment at two locations each from the upper, mid, and lower thirds of the uterus (six grid sample locations).

Obtain five measurements at each location to evaluate for the presence and degree of fibrosis:

1. Assess the relationship between SWE measurements in kiloPascals (kPa) and each MRI parameter among cases at the post-treatment timepoint.

2. Assess the relationship between SWE measurements and each MRI parameter in kPa among controls at one random timepoint.

3. Evaluate differences in kPa between cases and controls according to SWE at the post-treatment timepoint. The imaging study will be considered feasible if at least 85% (e.g., ≥15/17) of all enrolled cases achieve the diagnosability criteria by SWE, defined as having the interquartile range to median ratio (IQR/M) of the measurements (kPa) <=30% at any of the six locations.

Aim 2: Characterize uterine parameters after PRT. Hypothesis: Patients treated with PRT for colorectal/anal cancer will have decreased uterine volume and increased arterial resistive indices (blood flow) on US.

Approach:

2a. Perform US and estimate uterine volumes and arterial resistance. Use descriptive statistics to compare values to controls in the same age group.

2b. Perform MRI and describe changes in each parameter among cases between the pre- and post-treatment timepoints. Assess changes in: size of the uterus from baseline, junctional zone anatomy, endometrial thickness, cervical length, myometrial thickness, T2 signal of the myometrium (normalized for skeletal muscle signal acting as an internal control), and enhancement features.

Conditions

Uterine Injury

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Cases undergone PRT

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

Group Type: ACTIVE_COMPARATOR

MRI, SWE, and US evaluation

Intervention Type: 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

Controls

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

Group Type: SHAM_COMPARATOR

MRI, SWE, and US evaluation

Intervention Type: 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

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. Female

2. Less than 40 years old "at the time of pelvic radiation"

3. ≥ 18 and < 45 years of age "at time of enrollment"

4. Treated with PRT at UCH

5. Pelvic MRI taken before the pelvic radiation

Exclusion Criteria

1. Patients who underwent hysterectomy for treatment of a primary gynecologic malignancy

2. Patients that are currently pregnant

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sarah Milgrom, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado

Aurora, Colorado, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Guluzar Turan, MD

Role: CONTACT

Guluzar.Turan@cuanschutz.edu

(303) 399-0055

Jocelyn Phipers, NP

Role: CONTACT

Jocelyn.Phipers@cuanschutz.edu

303-724-7807

Facility Contacts

Sarah Milgrom, MD

Role: primary

SARAH.MILGROM@CUANSCHUTZ.EDU

720-848-0153

Other Identifiers

21-5074.cc

Identifier Type: -

Identifier Source: org_study_id