An interventional study of Gadobenate Dimeglumine and Gadobutrol in Brain Neoplasm, Lymphoma and Metastatic Malignant Neoplasm in the Brain, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-21.
Sponsored by M.D. Anderson Cancer Center · Not applicable, Interventional, and Diagnostic
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.
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 6 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.
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Exclusion Criteria:
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.
Drug: Gadobenate Dimeglumine · Drug: Gadobutrol · Procedure: Magnetic Resonance Imaging
Given IV
Also known as: Gd-BOPTA, MultiHance
Given IV
Also known as: BAY86-4875, Gadavist, Gadograf, Gadovist, Protovis, ZK 135079
Undergo MRI
Also known as: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging
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.
Time frame: 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.
Time frame: Baseline up to 120 days
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.
Time frame: Up to 120 days
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.
Time frame: Baseline up to 120 days
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.
Time frame: Up to 120 days
Differences in measured perfusion parameters before and after treatment.
Will examine differences in measured perfusion parameters before and after treatment.
Time frame: Baseline up to 120 days
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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M.D. Anderson Cancer Center