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Recruiting NCT04265430

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

Phase IV Interventional Malignant Oral Cavity Neoplasm Malignant Skull Base Neoplasm Osteoradionecrosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Contrast Agent, Magnetic Resonance Imaging, Quality-of-Life Assessment, Questionnaire Administration.
Who it may be relevant to
Registry conditions: Malignant Oral Cavity Neoplasm, Malignant Skull Base Neoplasm, Osteoradionecrosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Serial Magnetic Resonance Imaging of Longitudinal Radiotherapy-Attributable Normal Tissue Injury

Overview

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).

Detailed 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.

Interventions

  • Other Contrast Agent
    Given IV
  • Procedure Magnetic Resonance Imaging
    Undergo MRI
  • Other Quality-of-Life Assessment
    Ancillary studies
  • Other Questionnaire Administration
    Ancillary studies

Primary outcome measures

  • Radiotherapy-attributable imaging for normal tissue injury [Time frame: Up to 1 year]
  • Dose-response correlation between imaging biomarkers [Time frame: Up to 1 year]
  • Dose-response correlation between subsequent radiation-induced effects [Time frame: Up to 1 year]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • M D Anderson Cancer Center — Houston

Identifiers

NCT: NCT04265430 · PA14-0807 · NCI-2019-07862 · PA14-0807

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗