Health Trials

Serial Magnetic Resonance Imaging for the Prediction of Radiation-Induced Changes in Normal Tissue of Patients With Oral Cavity or Skull Base Tumors

ConditionsMalignant Oral Cavity NeoplasmMalignant Skull Base NeoplasmOsteoradionecrosis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

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).

Eligibility criteria

Qualifiers

Patients older than 18 years of age

Patients with good performance status (ECOG score 0-2)

Patients willing to give written informed consent.

Patients with histologically proven malignant neoplasms of the oral cavity, oropharynx or skull base.

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Contrast Agent
  • Magnetic Resonance Imaging
  • Quality-of-Life Assessment
  • Questionnaire Administration

Treatment groups

425 Participants
are divided into 2 treatment groups

Sponsors and collaborators

M.D. Anderson Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov