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RECRUITINGPhase 4INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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).

Who May Be Eligible (Plain English)

Who May Qualify: All Cohorts: - Patients older than 18 years of age - Patients with good performance status (ECOG score 0-2) - Patients willing to give written willing to sign a consent form. 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 Who Should NOT Join This Trial: - 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) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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)

Treatments Being Tested

OTHER

Contrast Agent

Given IV

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

Locations (1)

M D Anderson Cancer Center
Houston, Texas, United States