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

Conditions

• Orodental Injury

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Radiotherapy followed by chemotherapy — BEHAVIORAL
  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.

Study Details

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.

Key Dates

Start date

Sep 15, 2025

Status verified

Mar 2026

Primary completion

Dec 30, 2030

Completion

Dec 30, 2032

Study Design

Enrollment

300 participants (estimated)

Primary Outcome Measure

Overall Survival [ Time Frame: Up to 60 months ]

Central Contacts

• Stephen Lai, MD,PHD
  (713) 792-6528
  [email protected]

Locations (1)

Find similar trials in Houston, TX