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Quantitative Imaging Biomarker Prospective Validation of Dynamic Contrast-enhanced MRI as a Metric of Orodental Injury After Radiotherapy (QI-ProVE-MRI)
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: Provide signed and dated informed consent form. * Aged 18 years or older. * Have histologic evidence of malignant neoplasm that may have been obtained from the primary tumor or metastatic lymph node. * Have a clinical decision made to receive external beam radiation therapy (EBRT) with curative intent, with or without concomitant chemotherapy. * Have a good performance status (ECOG score 0-2) evaluated during screening (4 weeks prior to baseline imaging). * Be willing to comply with all study procedures. * Be willing to participate for the duration of the study. * Have elevated dosimetric risk mainly characterized by any of the following criteria: * D30\>50Gy: 30% of the whole-mandible volume received a dose greater than 50 Gy * V44 ≥ 42%: at least 42% of the volume received a dose of 44 Gy or more or * V58 ≥ 25%: at least 25% of the volume received a dose of 58 Gy or more. Exclusion Criteria: Unable to tolerate DW-MRI or DCE-MRI; * Having an estimated GFR \< 30 ml/min/1.73 m2; * Contraindication to MRI (e.g., non-MRI compatible metallic implants) * Pregnant females * Unable or unwilling to give written, informed consent to undergo MRI imaging. * Claustrophobia * Unable to obtain imaging studies of adequate quality to assess imaging-based biomarkers.
About the study
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.
What is being tested
- Radiotherapy followed by chemotherapy (behavioral)
Sponsor: M.D. Anderson Cancer Center · Participants: 300 · Started: Sep 15, 2025
Contact the study team
- Stephen Lai, MD,PHD · Phone: (713) 792-6528
Official record on ClinicalTrials.gov — NCT06586892
Locations in the U.S.
| Texas | The University of Texas M. D. Anderson Cancer Center, Houston |
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.