Novel MRI Techniques for the Characterization and Treatment Assessment of High Grade Brain Lesions
Novel Multi-Parameter Mapping and Analysis Techniques for Characterization and Treatment Assessment of High Grade Brain Lesions
2 other identifiers
interventional
6
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 5, 2019
CompletedFirst Posted
Study publicly available on registry
October 21, 2019
CompletedStudy Start
First participant enrolled
January 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2022
CompletedNovember 21, 2022
November 1, 2022
2.6 years
September 5, 2019
November 15, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
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.
Baseline
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.
Baseline up to 120 days
Secondary Outcomes (4)
Usefulness of T2 values in distinguishing non-enhancing components of the tumor
Up to 120 days
Quantification of T1 and proton density (PD) parameters
Baseline up to 120 days
Post-contrast T1 spin parameters with perfusion characteristics
Up to 120 days
Differences in measured perfusion parameters before and after treatment.
Baseline up to 120 days
Study Arms (1)
Diagnostic (MRI, gadobutrol, gadobenate dimeglumine)
EXPERIMENTALWithin 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.
Interventions
Given IV
Given IV
Undergo MRI
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ken-Pin Hwang, MD
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 5, 2019
First Posted
October 21, 2019
Study Start
January 10, 2020
Primary Completion
September 1, 2022
Study Completion
September 1, 2022
Last Updated
November 21, 2022
Record last verified: 2022-11