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

Osteoradionecrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04265430
• Other study ID #: PA14-0807
• Secondary ID: NCI-2019-07862PA
• Status: Recruiting
• Phase: Phase 4
• Start date: September 17, 2018
• Est. completion date: April 30, 2025

Study information

• Verified date: May 2024
• Source: M.D. Anderson Cancer Center
• Contact: Stephen Y. Lai
• Phone: 713-792-6920
• Email: sylai[@]mdanderson.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 425
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

Other:
• Contrast Agent
Given IV

Procedure:
• Magnetic Resonance Imaging
Undergo MRI

Other:
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiotherapy-attributable imaging for normal tissue injury	Will correlate whether post-therapy alterations in the observed multi-parametric imaging features can be used as surrogate bio-markers of normal tissue injury	Up to 1 year
Primary	Dose-response correlation between imaging biomarkers	Penalized spline mixed regression will be used to characterize the induced functional relationships between the delivered dose and imaging biomarkers identified at each imaging time point. Doses for which 95% confidence interval estimates of mean trajectory fail to overlap will characterize ranges that yield significantly different levels of dose-dependent modulation.	Up to 1 year
Primary	Dose-response correlation between subsequent radiation-induced effects	Penalized spline mixed regression will be used to characterize the induced functional relationships between the delivered dose and imaging biomarkers identified at each imaging time point. Doses for which 95% confidence interval estimates of mean trajectory fail to overlap will characterize ranges that yield significantly different levels of dosedependent modulation	Up to 1 year

External Links

•   MD Anderson Cancer Center