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

M.D. Anderson Cancer Center

Status and phase: Enrolling; Phase 4

Conditions: Osteoradionecrosis; Malignant Oral Cavity Neoplasm; Malignant Skull Base Neoplasm

Treatments: Other: Questionnaire Administration; Other: Quality-of-Life Assessment; Procedure: Magnetic Resonance Imaging; Other: Contrast Agent

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04265430

NCI-2019-07862 (Registry Identifier)

PA14-0807 (Other Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 425 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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425 participants in 2 patient groups

Cohort I (MRI after radiation therapy)

Experimental group

Description:

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.

Treatment:

Other: Contrast Agent

Procedure: Magnetic Resonance Imaging

Other: Quality-of-Life Assessment

Other: Questionnaire Administration

Cohort II (MRI after surgery)

Experimental group

Description:

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.

Treatment:

Other: Contrast Agent

Procedure: Magnetic Resonance Imaging

Other: Quality-of-Life Assessment

Other: Questionnaire Administration