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RecruitingPhase 4NCT04265430

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

Sponsor

M.D. Anderson Cancer Center

Enrollment

425 participants

Start Date

Sep 17, 2018

Study Type

INTERVENTIONAL

Conditions

OsteoradionecrosisMalignant Oral Cavity NeoplasmMalignant Skull Base Neoplasm

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

Min Age: 18 Years

Inclusion Criteria10

  • 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 Criteria2

  • 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)

Interventions

OTHERContrast Agent

Given IV

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

OTHERQuality-of-Life Assessment

Ancillary studies

OTHERQuestionnaire Administration

Ancillary studies

Locations(1)

M D Anderson Cancer Center

Houston, Texas, United States

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