A Novel Imaging Modality to Evaluate Radiation-Induced Uterine Injury
University of Colorado, Denver
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.
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 s…
Eligibility
- Age range
- 18–45 years
- Sex
- Female
- Healthy volunteers
- No
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
Interventions
- Diagnostic TestMRI, 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
Location
- University of ColoradoAurora, Colorado