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

Last updated: October 28, 2024
Sponsor: M.D. Anderson Cancer Center
Overall Status: Active - Recruiting

Phase

4

Condition

Neoplasms

Treatment

Contrast Agent

Quality-of-Life Assessment

Questionnaire Administration

Clinical Study ID

NCT04265430
PA14-0807
PA14-0807
NCI-2019-07862
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Patients with histologically proven malignant neoplasms of the oral cavity and skullbase

  • Patients whom, currently or previously, dispositioned to treatment with radiotherapy

  • Patients with good performance status (Eastern Cooperative Oncology Group [ECOG]score 0-2)

  • Patients willing to give written informed consent

Exclusion

Exclusion Criteria:

  • Patients unable to tolerate diffusion weighted (DW)-MRI or dynamic contrast-enhanced (DCE)-MRI or having an estimated glomerular filtration rate (GFR) < 60ml/min/1.73m^2

  • Patients with contraindication to MRI (e.g. non-MRI compatible metallic implants)

Study Design

Total Participants: 425
Treatment Group(s): 4
Primary Treatment: Contrast Agent
Phase: 4
Study Start date:
September 17, 2018
Estimated Completion Date:
April 30, 2025

Study Description

PRIMARY OBJECTIVES:

I. Demonstrate the feasibility of serial magnetic resonance (MR) imaging biomarkers for assessment of early, intermediate, and late radiotherapy-attributable physiologic alteration of tumor and normal tissues and the kinetics thereof.

II. Develop MR-biomarker inclusive predictive models for development of radiotherapy-attributable normal tissue injury.

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.

Connect with a study center

  • M D Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

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