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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
RECRUITINGPhase 4Sponsored by M.D. Anderson Cancer Center
Actively Recruiting
PhasePhase 4
SponsorM.D. Anderson Cancer Center
Started2018-09-17
Est. completion2031-09-01
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT04265430
Summary
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).
Eligibility
Age: 18 Years+Healthy volunteers accepted
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)
Conditions4
CancerMalignant Oral Cavity NeoplasmMalignant Skull Base NeoplasmOsteoradionecrosis
Locations1 site
M D Anderson Cancer Center
Houston, Texas, 77030
Stephen Y. Lai713-792-6920
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Actively Recruiting
PhasePhase 4
SponsorM.D. Anderson Cancer Center
Started2018-09-17
Est. completion2031-09-01
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT04265430