Serial Magnetic Resonance Imaging for the Prediction of Radiation-Induced Changes in Normal Tissue of Patients With Oral Cavity or Skull Base Tumors
Primary Purpose
Malignant Oral Cavity Neoplasm, Malignant Skull Base Neoplasm, Osteoradionecrosis
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Contrast Agent
Magnetic Resonance Imaging
Quality-of-Life Assessment
Questionnaire Administration
Sponsored by
About this trial
This is an interventional diagnostic trial for Malignant Oral Cavity Neoplasm
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)
Sites / Locations
- M D Anderson Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Cohort I (MRI after radiation therapy)
Cohort II (MRI after surgery)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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
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.
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04265430
First Posted
December 3, 2019
Last Updated
October 4, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT04265430
Brief Title
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
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 17, 2018 (Actual)
Primary Completion Date
April 30, 2025 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Oral Cavity Neoplasm, Malignant Skull Base Neoplasm, Osteoradionecrosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
425 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cohort I (MRI after radiation therapy)
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort II (MRI after surgery)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Contrast Agent
Other Intervention Name(s)
Contrast, Contrast Drugs, contrast material, Contrast Medium
Intervention Description
Given IV
Intervention Type
Procedure
Intervention Name(s)
Magnetic Resonance Imaging
Other Intervention Name(s)
Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging
Intervention Description
Undergo MRI
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Radiotherapy-attributable imaging for normal tissue injury
Description
Will correlate whether post-therapy alterations in the observed multi-parametric imaging features can be used as surrogate bio-markers of normal tissue injury
Time Frame
Up to 1 year
Title
Dose-response correlation between imaging biomarkers
Description
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.
Time Frame
Up to 1 year
Title
Dose-response correlation between subsequent radiation-induced effects
Description
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
Time Frame
Up to 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephen Y. Lai
Phone
713-792-6920
Email
sylai@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Y Lai
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen Y. Lai
Phone
713-792-6920
First Name & Middle Initial & Last Name & Degree
Stephen Y. Lai
12. IPD Sharing Statement
Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center
Learn more about this trial
Serial Magnetic Resonance Imaging for the Prediction of Radiation-Induced Changes in Normal Tissue of Patients With Oral Cavity or Skull Base Tumors
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