New imaging technique to assess uterine damage from radiation
A Novel Imaging Modality to Evaluate Radiation-Induced Uterine Injury
This study is testing a new imaging method to see if it can help find damage in the uterus caused by radiation in young women who have had treatment for colorectal or anal cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 22 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | University of Colorado, Denver Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT06518174 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate the effectiveness of a novel imaging technique, shear-wave elastography (SWE), combined with magnetic resonance imaging (MRI), in identifying radiation-induced uterine injury in female patients who have undergone pelvic radiation therapy for colorectal or anal cancer. Participants aged 15 to 39 years who received at least 50 Gy of radiation at least 12 months prior will be recruited. The study will involve transabdominal and possibly transvaginal ultrasound, along with SWE and MRI, to characterize uterine parameters and assess the presence of fibrosis. The findings will help inform future therapeutic interventions for radiation-induced uterine damage.
Who should consider this trial
Good fit: Ideal candidates are females aged 15 to 39 who have received at least 50 Gy of pelvic radiation therapy for colorectal or anal cancer at least 12 months prior.
Not a fit: Patients who have undergone a hysterectomy for gynecologic malignancy or are currently pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic techniques for detecting uterine injuries caused by radiation, potentially guiding better treatment options.
How similar studies have performed: While the use of SWE and MRI for this specific application is novel, similar imaging techniques have shown promise in other contexts of assessing tissue damage.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Aurora, Colorado
- University of Colorado — Aurora, Colorado, United States (Recruiting)
Study contacts
- Principal investigator: Sarah Milgrom, MD — University of Colorado, Denver
- Study coordinator: Guluzar Turan, MD
- Email: Guluzar.Turan@cuanschutz.edu
- Phone: (303) 399-0055
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.