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Serial Magnetic Resonance Imaging for the Prediction of Radiation-Induced Changes in Normal Tissue of Patients With Oral Cavity or Skull Base Tumors
Study Purpose
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).
Recruitment Criteria
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
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Inclusion Criteria:
Exclusion Criteria:
- - Patients unable to tolerate diffusion weighted (DW)-MRI or dynamic contrast-enhanced
(DCE)-MRI or having an estimated glomerular filtration rate (GFR) < 60 ml/min/1.73m^2.
- Patients with contraindication to MRI (e.g. non-MRI compatible metallic implants)Trial Details
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
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The person who is responsible for the scientific and technical direction of the entire clinical study.
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
PRIMARY OBJECTIVES:
- 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.Arms
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.
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.
Interventions
Other: - Contrast Agent
Given IV
Procedure: - Magnetic Resonance Imaging
Undergo MRI
Other: - Quality-of-Life Assessment
Ancillary studies
Other: - Questionnaire Administration
Ancillary studies
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Recruiting
Address
M D Anderson Cancer Center
Houston, Texas, 77030
Site Contact
Stephen Y. Lai
[email protected]
713-792-6920
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