Using contrast-enhanced MRI to measure jaw and mouth injury after radiation for head and neck cancer

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

This project will test if contrast-enhanced MRI scans can detect and track jaw bone and soft-tissue damage in people receiving radiation for head and neck cancer.

Quick facts

• Study type: Observational
• Enrollment: 300 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: M.D. Anderson Cancer Center (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT06586892 on ClinicalTrials.gov

What this trial studies

This prospective observational study will enroll 200 patients with elevated mandibular dosimetric risk who are receiving curative-intent external-beam radiation for primary head and neck cancer. Serial multi-parametric DCE-MRI scans measuring Ktrans and Ve will be acquired per a standardized manual of procedures while patients receive standard IMRT or IMPT; imaging will not change clinical treatment. Clinical, dental, functional outcomes and patient-reported outcome questionnaires will be collected and correlated with imaging biomarkers over follow-up of up to 36 months to capture an anticipated ~20% event rate for osteoradionecrosis. The overall aim is prospective qualification and validation of DCE-MRI parameters as quantitative imaging biomarkers of bone and soft-tissue injury after radiotherapy.

Who should consider this trial

Good fit: Adults (≥18) with histologically confirmed primary head and neck cancer planning curative external-beam radiation (with or without chemotherapy) who meet elevated mandibular dosimetric criteria (D30>50Gy, V44≥42%, or V58≥25%).

Not a fit: Patients without elevated mandibular radiation exposure, those unable to tolerate contrast-enhanced MRI, or those with poor performance status are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, validated DCE-MRI biomarkers could allow earlier detection and better monitoring of radiation-related jaw bone and soft-tissue injury, potentially guiding preventive care.

How similar studies have performed: Small retrospective and preliminary studies have suggested DCE-MRI parameters may relate to osteoradionecrosis risk, but large prospective validation like this is novel.

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.

Where this trial is running

Houston, Texas

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

Study contacts

• Principal investigator: Stephen Lai, MD,PHD — M.D. Anderson Cancer Center
• Study coordinator: Stephen Lai, MD,PHD

Conditions Orodental Injury