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

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).

Study Overview

• Status: Recruiting
• Conditions: Osteoradionecrosis; Malignant Skull Base Neoplasm; Malignant Oral Cavity Neoplasm
• Intervention / Treatment: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Procedure: Magnetic Resonance Imaging; Other: Contrast Agent

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.

• Study Type: Interventional
• Enrollment (Estimated): 425
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Stephen Y. Lai; Phone Number: 713-792-6920; Email: sylai@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • M D Anderson Cancer Center
      • Principal Investigator: Stephen Y. Lai
      • Contact: Stephen Y. Lai; Phone Number: 713-792-6920

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

All Cohorts:

• Patients older than 18 years of age
• Patients with good performance status (ECOG score 0-2)
• Patients willing to give written informed consent.

Cohort 1 (Individuals without ORN or MRONJ):

• Patients with histologically proven malignant neoplasms of the oral cavity, oropharynx or skull base.
• Patients currently dispositioned to treatment with radiotherapy and/or antiresorptive or antiangiogenic medication therapy

Cohort 2 (Individuals with ORN or MRONJ):

• Patients with a clinical diagnosis of ORN or MRONJ following treatment for cancer
• Patients previously dispositioned to treatment with radiotherapy and/or antiresorptive or antiangiogenic medication therapy

Exclusion Criteria:

• Patients unable to tolerate DW-MRI or DCE-MRI or having an estimated GFR < 30ml/min/1.73m2.
• Patients with contraindication to MRI (e.g. non-MRI compatible metallic implants)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort I (MRI after radiation therapy); Patients may receive a contrast agent 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.	Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; Procedure: Magnetic Resonance Imaging; Undergo MRI; Other Names: MRI; Magnetic Resonance Imaging Scan; Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance; MR Imaging; MRI Scan; NMR Imaging; NMRI; Nuclear Magnetic Resonance Imaging; Other: Contrast Agent; Given IV; Other Names: Contrast; Contrast Drugs; contrast material; Contrast Medium
Experimental: Cohort II (MRI after surgery); 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.	Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; Procedure: Magnetic Resonance Imaging; Undergo MRI; Other Names: MRI; Magnetic Resonance Imaging Scan; Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance; MR Imaging; MRI Scan; NMR Imaging; NMRI; Nuclear Magnetic Resonance Imaging; Other: Contrast Agent; Given IV; Other Names: Contrast; Contrast Drugs; contrast material; Contrast Medium

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiotherapy-attributable imaging for normal tissue injury	Will correlate whether post-therapy alterations in the observed multi-parametric imaging features can be used as surrogate bio-markers of normal tissue injury	Up to 1 year
Dose-response correlation between imaging biomarkers	Penalized spline mixed regression will be used to characterize the induced functional relationships between the delivered dose and imaging biomarkers identified at each imaging time point. Doses for which 95% confidence interval estimates of mean trajectory fail to overlap will characterize ranges that yield significantly different levels of dose-dependent modulation.	Up to 1 year
Dose-response correlation between subsequent radiation-induced effects	Penalized spline mixed regression will be used to characterize the induced functional relationships between the delivered dose and imaging biomarkers identified at each imaging time point. Doses for which 95% confidence interval estimates of mean trajectory fail to overlap will characterize ranges that yield significantly different levels of dosedependent modulation	Up to 1 year

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Stephen Y Lai, 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 17, 2018
• Primary Completion (Estimated): September 1, 2031
• Study Completion (Estimated): September 1, 2031

Study Registration Dates

• First Submitted: December 3, 2019
• First Submitted That Met QC Criteria: February 10, 2020
• First Posted (Actual): February 11, 2020

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Wounds and Injuries; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Radiation Injuries; Mouth Neoplasms; Osteoradionecrosis; Investigative Techniques; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals; Chemistry Techniques, Analytical; Spectrum Analysis; Diagnostic Uses of Chemicals; Magnetic Resonance Spectroscopy; Contrast Media
• Other Study ID Numbers: PA14-0807 (Other Identifier: M D Anderson Cancer Center); NCI-2019-07862 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No