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

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.

Study Overview

• Status: Recruiting
• Conditions: Orodental Injury
• Intervention / Treatment: Behavioral: Radiotherapy followed by chemotherapy

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 Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Stephen Lai, MD,PHD; Phone Number: (713) 792-6528; Email: sylai@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas M. D. Anderson Cancer Center
      • Contact: Stephen Lai, MD, PHD; Phone Number: 713-792-6528; Email: sylai@mdanderson.org
      • Principal Investigator: Stephen Lai, MD, PHD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

MD Anderson Cancer Center

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall Survival	Up to 60 months

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Institute of Dental and Craniofacial Research (NIDCR)
• Investigators: Principal Investigator: Stephen Lai, MD,PHD, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2025
• Primary Completion (Estimated): December 30, 2030
• Study Completion (Estimated): December 30, 2032

Study Registration Dates

• First Submitted: September 4, 2024
• First Submitted That Met QC Criteria: September 4, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 2024-0406; NCI-2024-06902 (Other Identifier: National Cancer Institute)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No