RecruitingNCT06586892

Quantitative Imaging Biomarker Prospective Validation of Dynamic Contrast-enhanced MRI as a Metric of Orodental Injury After Radiotherapy (QI-ProVE-MRI)


Sponsor

M.D. Anderson Cancer Center

Enrollment

300 participants

Start Date

Sep 15, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

This research will focus on the prospective qualification and validation of dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) candidate biomarkers (i.e., Ktrans and Ve) to assess the natural history of osteoradionecrosis (ORN) and treatment for this devastating complication related to irradiation of head and neck cancers. The investigations will also include assessment of DCE-MRI candidate biomarkers for pre-qualification as quantitative imaging biomarkers of soft-tissue structures.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a behavioral approach called Radiotherapy followed by chemotherapy for people with orodental injury. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALRadiotherapy followed by chemotherapy

Researchers would like to test the accuracy of the MRI data being used for this study. If you agree, you will have 2 additional MRI scans within 2 weeks before Visit 1. The first 90 participants who agree will be selected to have the following scans: * 35 participants will be scanned 2 times on one MRI device (Device #1). * 35 participants will be scanned 2 times on another MRI device (Device #2). * 20 participants will be scanned 1 time on both MRI devices (Device #1 and #2). If you agree and you are chosen, the study doctor will tell you if you will have scans on 1. or 2 MRI devices.


Locations(1)

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, United States

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NCT06586892