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

Conditions

• Malignant Oral Cavity Neoplasm
• Malignant Skull Base Neoplasm
• Osteoradionecrosis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Contrast Agent — OTHER
  Given IV
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Quality-of-Life Assessment — OTHER
  Ancillary studies
• Questionnaire Administration — OTHER
  Ancillary studies

Study Details

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).

Key Dates

Start date

Sep 17, 2018

Status verified

May 2026

Primary completion

Sep 1, 2031

Completion

Sep 1, 2031

Study Design

Enrollment

425 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

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.

Primary Outcome Measure

Radiotherapy-attributable imaging for normal tissue injury [ Time Frame: Up to 1 year ]

Central Contacts

• Stephen Y. Lai
  713-792-6920
  [email protected]

Locations (1)

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