Clinical trial NCT04265430: Serial Magnetic Resonance Imaging for the Prediction of Radiation-Induced Changes in Normal Tissue of Patients With Oral Cavity or Skull Base Tumors
Official title: Serial Magnetic Resonance Imaging of Longitudinal Radiotherapy-Attributable Normal Tissue Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Malignant Oral Cavity Neoplasm
Malignant Skull Base Neoplasm
Osteoradionecrosis
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-02-11
Enrollment: 425
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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).

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.

Eligibility criteria: Inclusion Criteria:

* Patients with histologically proven malignant neoplasms of the oral cavity and skull base
* 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 Criteria:

* Patients unable to tolerate diffusion weighted (DW)-MRI or dynamic contrast-enhanced (DCE)-MRI or having an estimated glomerular filtration rate (GFR) \< 60 ml/min/1.73m\^2
* Patients with contraindication to MRI (e.g. non-MRI compatible metallic implants)

Primary outcomes:
measure: Radiotherapy-attributable imaging for normal tissue injury
timeFrame: Up to 1 year
measure: Dose-response correlation between imaging biomarkers
timeFrame: Up to 1 year
measure: Dose-response correlation between subsequent radiation-induced effects
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Stephen Y Lai
role: PRINCIPAL_INVESTIGATOR
References: