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

Recruiting now

Conditions studied: Orodental Injury

In brief

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 facts

Study ID

NCT06586892

Run by

M.D. Anderson Cancer Center

People needed

300

Starts

2025-09-15

Expected to finish

2032-12-30

Last updated by the study team

2026-03-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• The University of Texas M. D. Anderson Cancer Center — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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