Novel MRI Techniques for the Characterization and Treatment Assessment of High Grade Brain Lesions
Primary Purpose
Brain Neoplasm, Lymphoma, Metastatic Malignant Neoplasm in the Brain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Gadobenate Dimeglumine
Gadobutrol
Magnetic Resonance Imaging
Sponsored by
About this trial
This is an interventional diagnostic trial for Brain Neoplasm
Eligibility Criteria
Inclusion Criteria:
- At least one enhancing lesion, aggregate of enhancing foci, and nonenhancing lesion measuring at least 1 cm in size and is suspected to be a high grade brain neoplasm
- Patient is dispositioned to surgery, chemotherapy and/or radiation therapy
- Patient is able to understand and give own consent to participate in the study
Exclusion Criteria:
- Contraindication to magnetic resonance imaging (MRI) as assessed by the investigator's standard of care magnetic resonance (MR) screening procedure, which includes implants or devices that are unsafe in the magnetic environment
- Contraindication or history of allergy to Gadolinium-based (gadobutrol [Gadovist], gadobenate dimeglumine (Multihance]) intravenous contrast
- Verbal confirmation of pregnancy or a positive pregnancy test result in patient record
- Prior partial (greater than 50%) or gross total resection of primary tumor
- Prior chemotherapy or radiation treatment to brain
Sites / Locations
- M D Anderson Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Diagnostic (MRI, gadobutrol, gadobenate dimeglumine)
Arm Description
Within 21 days before standard of care chemotherapy and/or radiation therapy, patients undergo an MRI scan for the first set of images. Patients then receive either gadobutrol or gadobenate dimeglumine IV and undergo an MRI for the second set of images. All MRI scans take a total of 60 minutes to complete. Patients then repeat the MRI scans 120 days after standard of care chemotherapy and/or radiation therapy.
Outcomes
Primary Outcome Measures
Differences in T2 spin parameters
Will use 3-dimensional (3D) quantitative mapping to determine whether different in T2 spin parameters exist between the peritumoral area and normal brain in the contralateral hemisphere. If the data are normal, will calculate 95% confidence intervals around the mean paired difference in baseline T2 between the peritumoral and normal regions. If the data are not normally distributed, ordered statistics will be calculated, and bootstrapping will be used to estimate the 2.5th and 97.5th percentiles for the median.
Differences between peritumoral and normal brain
Will use 3D quantitative mapping to examine how differences between peritumoral and normal brain in the contralateral hemisphere change before and after treatment. The regions of interest drawn on measured magnetic resonance (MR) spin parameter and MR perfusion parameter values will be grouped according to time point (pre- or post-treatment) and area (peritumoral, tumoral, and normal brain in the contralateral hemisphere). Descriptive statistics and boxplots of these measurements, paired differences between areas and paired differences between time points will be calculated. Will calculate 95% confidence intervals around the mean paired change between area differences at baseline and post-treatment.
Secondary Outcome Measures
Usefulness of T2 values in distinguishing non-enhancing components of the tumor
Will use area under an receive operating curve to determine whether T2 values might be useful in distinguishing non-enhancing components of the tumor as well as predicting response to treatment. Paired data from all patients will be used in this analysis.
Quantification of T1 and proton density (PD) parameters
Will quantify T1 and PD spin parameters of the peritumoral area and their differences before and after treatment.
Post-contrast T1 spin parameters with perfusion characteristics
Will examine post-contrast T1 spin parameters with perfusion characteristics as measured by an established dynamic susceptibility contrast technique.
Differences in measured perfusion parameters before and after treatment.
Will examine differences in measured perfusion parameters before and after treatment.
Full Information
NCT ID
NCT04132843
First Posted
September 5, 2019
Last Updated
November 15, 2022
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT04132843
Brief Title
Novel MRI Techniques for the Characterization and Treatment Assessment of High Grade Brain Lesions
Official Title
Novel Multi-Parameter Mapping and Analysis Techniques for Characterization and Treatment Assessment of High Grade Brain Lesions
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
January 10, 2020 (Actual)
Primary Completion Date
September 1, 2022 (Actual)
Study Completion Date
September 1, 2022 (Actual)
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 trial studies different magnetic resonance imaging (MRI) techniques and their ability to provide clearer pictures of lesions in patients with high grade brain lesions. An MRI is a type of imaging scan. Using different MRI techniques to produce clearer images of the brain may help researchers learn about the features of brain lesions and the effects of chemotherapy and/or radiation therapy.
Detailed Description
PRIMARY OBJECTIVES:
I. To use 3-dimensional (3D) quantitative mapping to determine whether differences in T2 spin parameters exist between the peritumoral area and normal brain in the contralateral hemisphere at baseline.
II. To use 3D quantitative mapping to examine how differences between peritumoral and normal brain in the contralateral hemisphere change before and after treatment.
SECONDARY OBJECTIVES:
I. Determine whether T2 values might be useful in distinguishing non-enhancing components of the tumor as well as predicting response to treatment.
II. Quantify T1 and proton density (PD) spin parameters of the peritumoral area and their differences before and after treatment.
III. Examine post-contrast T1 spin parameters with perfusion characteristics as measured by an established dynamic susceptibility contrast (DSC) technique.
IV. Examine differences in measured perfusion parameters (blood volume and mean transit time of each tumor) before and after treatment.
OUTLINE:
Within 21 days before standard of care chemotherapy and/or radiation therapy, patients undergo an MRI scan for the first set of images. Patients then receive either gadobutrol or gadobenate dimeglumine intravenously (IV) and undergo an MRI for the second set of images. All MRI scans take a total of 60 minutes to complete. Patients then repeat the MRI scans 120 days after standard of care chemotherapy and/or radiation therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Neoplasm, Lymphoma, Metastatic Malignant Neoplasm in the Brain, Recurrent Malignant Brain Neoplasm
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diagnostic (MRI, gadobutrol, gadobenate dimeglumine)
Arm Type
Experimental
Arm Description
Within 21 days before standard of care chemotherapy and/or radiation therapy, patients undergo an MRI scan for the first set of images. Patients then receive either gadobutrol or gadobenate dimeglumine IV and undergo an MRI for the second set of images. All MRI scans take a total of 60 minutes to complete. Patients then repeat the MRI scans 120 days after standard of care chemotherapy and/or radiation therapy.
Intervention Type
Drug
Intervention Name(s)
Gadobenate Dimeglumine
Other Intervention Name(s)
Gd-BOPTA, MultiHance
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
Gadobutrol
Other Intervention Name(s)
BAY86-4875, Gadavist, Gadograf, Gadovist, Protovis, ZK 135079
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, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging
Intervention Description
Undergo MRI
Primary Outcome Measure Information:
Title
Differences in T2 spin parameters
Description
Will use 3-dimensional (3D) quantitative mapping to determine whether different in T2 spin parameters exist between the peritumoral area and normal brain in the contralateral hemisphere. If the data are normal, will calculate 95% confidence intervals around the mean paired difference in baseline T2 between the peritumoral and normal regions. If the data are not normally distributed, ordered statistics will be calculated, and bootstrapping will be used to estimate the 2.5th and 97.5th percentiles for the median.
Time Frame
Baseline
Title
Differences between peritumoral and normal brain
Description
Will use 3D quantitative mapping to examine how differences between peritumoral and normal brain in the contralateral hemisphere change before and after treatment. The regions of interest drawn on measured magnetic resonance (MR) spin parameter and MR perfusion parameter values will be grouped according to time point (pre- or post-treatment) and area (peritumoral, tumoral, and normal brain in the contralateral hemisphere). Descriptive statistics and boxplots of these measurements, paired differences between areas and paired differences between time points will be calculated. Will calculate 95% confidence intervals around the mean paired change between area differences at baseline and post-treatment.
Time Frame
Baseline up to 120 days
Secondary Outcome Measure Information:
Title
Usefulness of T2 values in distinguishing non-enhancing components of the tumor
Description
Will use area under an receive operating curve to determine whether T2 values might be useful in distinguishing non-enhancing components of the tumor as well as predicting response to treatment. Paired data from all patients will be used in this analysis.
Time Frame
Up to 120 days
Title
Quantification of T1 and proton density (PD) parameters
Description
Will quantify T1 and PD spin parameters of the peritumoral area and their differences before and after treatment.
Time Frame
Baseline up to 120 days
Title
Post-contrast T1 spin parameters with perfusion characteristics
Description
Will examine post-contrast T1 spin parameters with perfusion characteristics as measured by an established dynamic susceptibility contrast technique.
Time Frame
Up to 120 days
Title
Differences in measured perfusion parameters before and after treatment.
Description
Will examine differences in measured perfusion parameters before and after treatment.
Time Frame
Baseline up to 120 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
At least one enhancing lesion, aggregate of enhancing foci, and nonenhancing lesion measuring at least 1 cm in size and is suspected to be a high grade brain neoplasm
Patient is dispositioned to surgery, chemotherapy and/or radiation therapy
Patient is able to understand and give own consent to participate in the study
Exclusion Criteria:
Contraindication to magnetic resonance imaging (MRI) as assessed by our standard of care magnetic resonance (MR) screening procedure, which includes implants or devices that are unsafe in the magnetic environment
Contraindication or history of allergy to Gadolinium-based (gadobutrol [Gadovist], gadobenate dimeglumine (Multihance]) intravenous contrast
Verbal confirmation of pregnancy or a positive pregnancy test result in patient record
Prior partial (greater than 50%) or gross total resection of primary tumor
Prior chemotherapy or radiation treatment to brain
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ken-Pin Hwang, MD
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
12. IPD Sharing Statement
Links:
URL
http://www.mdanderson.org
Description
M D Anderson Cancer Center
Learn more about this trial
Novel MRI Techniques for the Characterization and Treatment Assessment of High Grade Brain Lesions
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