TerminatedNot Applicable

A Novel Imaging Modality to Evaluate Radiation-Induced Uterine Injury

Stopped: PI is leaving the Institution.

United States8 participantsStarted 2025-02-25

Plain-language 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.

Who can participate

Age range

18 Years – 45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Exclusion criteria

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

SWE feasibility

Timeframe: Up to six months

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

Timeframe: Up to six months

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

Timeframe: Up to six months

Trial details

NCT IDNCT06518174

SponsorUniversity of Colorado, Denver

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05-31

View on ClinicalTrials.gov More Uterine Injury trials

Plain-language summary

Who can participate

Age range

18 Years – 45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Exclusion criteria

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

What they're measuring

SWE feasibility

Timeframe: Up to six months

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

Timeframe: Up to six months

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

Timeframe: Up to six months