NCT04265430

Serial Magnetic Resonance Imaging for the Prediction of Radiation-Induced Changes in Normal Tissue of Patients With Oral Cavity or Skull Base Tumors

Serial Magnetic Resonance Imaging of Longitudinal Radiotherapy-Attributable Normal Tissue Injury

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 425 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase IV trial studies how well serial magnetic resonance imaging (MRI) after radiation therapy works in predicting radiation-induced changes in the normal tissue of patients with oral cavity or skull base tumors. Performing MRIs after radiation therapy for patients with oral cavity or skull base tumors may help to predict osteoradionecrosis (a change in non-cancerous tissue).

Detailed description

PRIMARY OBJECTIVES: I. Demonstrate the feasibility of serial magnetic resonance (MR) imaging biomarkers for assessment of early, intermediate, and late radiotherapy-attributable physiologic alteration of tumor and normal tissues and the kinetics thereof. II. Develop MR-biomarker inclusive predictive models for development of radiotherapy-attributable normal tissue injury. III. Define dose-response relationships between imaging biomarkers and subsequent radiation-induced effects. OUTLINE: Patients are assigned to 1 of 2 cohorts. COHORT I: Patients may receive a contrast agent intravenously (IV) and then undergo an MRI over 45-60 minutes at baseline, 3-5 weeks after starting standard of care radiation therapy, and then at 2 months, 6 months, 12 months, and 3 years after completing radiation therapy. COHORT II: Patients may receive a contrast agent IV and then undergo an MRI over 45-60 minutes at baseline, and at 5-10 weeks and 12 months after standard of care surgery.

Conditions

• Malignant Oral Cavity Neoplasm
• Malignant Skull Base Neoplasm
• Osteoradionecrosis

Interventions

Type	Name	Description
OTHER	Contrast Agent	Given IV
PROCEDURE	Magnetic Resonance Imaging	Undergo MRI
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2018-09-17
• Primary completion: 2031-09-01
• Completion: 2031-09-01
• First posted: 2020-02-11
• Last updated: 2025-11-14

Locations

1 site across 1 country: United States