An interventional study of Dynamic Contrast-Enhanced Magnetic Resonance Imaging and Questionnaire Administration in Head and Neck Cancer, sponsored by M.D. Anderson Cancer Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-16.
Sponsored by M.D. Anderson Cancer Center · Not applicable, Interventional, and Diagnostic
This trial studies how well dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) works in diagnosing osteoradionecrosis in patients with head and neck cancer that is primary, has come back, or has spread to other places in the body who are undergoing radiation therapy. DCE-MRI may help doctors to predict osteoradionecrosis in patient with head and neck cancer undergoing radiation therapy.
PRIMARY OBJECTIVES:
I. To determine whether DCE-MRI following external beam radiation therapy (EBRT) can be used to reliably predict osteoradionecrosis (ORN).
SECONDARY OBJECTIVES:
I. Define dose-response relationships between DCE-MRI derived imaging biomarkers and subsequent development of ORN.
II. Evaluate the use of DCE-MRI parameters to monitor ORN response to treatment.
III. Assess the use of DCE-MRI parameters in preoperative planning in advanced ORN subjects.
IV. Develop MRI-based biomarkers inclusive predictive models for development of radiotherapy-attributable tissue injury within the field of radiation.
V. Determine the association of patient-related outcomes (PROs) to clinical and imaging findings of tissue damage, such as the onset of ORN.
OUTLINE: Patients are assigned to 1 of 4 cohorts.
COHORT 1: Patients with newly diagnosed tumors undergo DCE-MRI within 4 weeks prior to the first radiation fraction, within 3-5 weeks after radiation start, and at 2, 6, 12, 24, and 36 months post radiation. Patients who were previously irradiated and are at various stages of oncologic follow-up undergo DCE-MRI for a total of 2-5 times at baseline and at 6, 12, 24, 36, and/or 48 months post radiation. Patients in the third or subsequent years post treatment may undergo subsequent yearly imaging studies.
COHORT 2: Patients undergo DCE-MRI within 4 weeks prior to the first re-radiation fraction, within 3-5 weeks after radiation start, and at 2, 6, 12, 24, and 36 months post radiation.
COHORT 3: Patients undergo DCE-MRI before and at 2 and 6 months post ORN treatment. Patients may undergo DCE-MRI during the mid-ORN treatment.
COHORT 4: Patients undergo DCE-MRI within 4 weeks prior to and at 5-10 weeks and 12 months post surgery.
Exclusion Criteria:
Patients with newly diagnosed tumors undergo DCE-MRI within 4 weeks prior to the first radiation fraction, within 3-5 weeks after radiation start, and at 2, 6, 12, 24, and 36 months post radiation. Patients who were previously irradiated and are at various stages of oncologic follow-up undergo DCE-MRI for a total of 2-5 times at baseline and at 6, 12, 24, 36, and/or 48 months post radiation. Patients in the third or subsequent years post treatment may undergo subsequent yearly imaging studies.
Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging · Other: Questionnaire Administration
Patients undergo DCE-MRI within 4 weeks prior to the first re-radiation fraction, within 3-5 weeks after radiation start, and at 2, 6, 12, 24, and 36 months post radiation.
Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging · Other: Questionnaire Administration
Patients undergo DCE-MRI before and at 2 and 6 months post ORN treatment. Patients may undergo DCE-MRI during the mid-ORN treatment.
Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging · Other: Questionnaire Administration
Patients undergo DCE-MRI within 4 weeks prior to and at 5-10 weeks and 12 months post surgery.
Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging · Other: Questionnaire Administration
Undergo DCE-MRI
Also known as: DCE MRI, DCE-MRI, DYNAMIC CONTRAST ENHANCED MRI
Ancillary studies
DCE-MRI Derived Parameters Following External Beam Radiation Therapy (EBRT) and Subsequent Development of Osteoradionecrosis (ORN)
Spatiotemporal parameter maps extracted from patient DCE-MRI scans. Clinical staging of developing or existing ORN conducted according to the CTCAE 4.0.
Time frame: 5 years
Dose-Response Relationships Between DCE-MRI Derived Imaging Biomarkers and Subsequent Development of Osteoradionecrosis (ORN)
Voxel-by-voxel correlation of delivered radiation dose to mandible and DCE-MRI parameter changes determined to establish a dose-biomarker response relationship.
Time frame: 5 years
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M.D. Anderson Cancer Center