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
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