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

Not yet recruiting

• Conditions: Orodental Injury

• Registration Number: NCT06586892
• Lead Sponsor: M.D. Anderson Cancer Center

Brief 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.

Detailed Description

This prospective observational study will acquire DCE-MRI data from 200 evaluable patients, specifically with an elevated dosimetric risk to assure an event rate of 20% by 36 months post-radiation, sufficient to demonstrate biomarker performance in the clinical cohort most reflective of relative ORN risk. The final study cohort will consist of individuals undergoing definitive radiotherapy for primary head and neck malignancy. The study subjects will include patients with primarily elevated risk of ORN based on clinical (e.g., pre-RT dental procedures) and dosimetric risk factors we established in prior work (e.g., D30\>50Gy, V44 ≥ 42%, or V58 ≥ 25%). All subjects will receive standard IMRT or IMPT as part of their standard clinical care, and treatment plans delivered will be in no way modified based on experimental imaging. Multi-parametric DCE-MRI imaging will be serially performed as per this study's manual of procedures. Clinical data regarding for evaluation of possible dental, mandibular, as well as other normal tissue organs-at-risk side effects will be collected prospectively from medical and dental records for correlation with the DCE-MRI imaging biomarkers. Functional outcomes and patient-reported outcomes questionnaires will be completed to detail outcomes of the continuum of treatment and survivorship.

Study Timeline

• Study First Submitted: 2024-09-04
• Study First Submitted QC: 2024-09-04
• Study First Posted: 2024-09-19
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-27
• Last Update Posted: 2025-03-30
• Study Start: 2025-10-31
• Primary Completion: 2030-12-30
• Study Completion: 2032-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall Survival	Up to 60 months