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Trial record 6 of 13 for:    Recruiting, Enrolling by invitation Studies | Interventional Studies | Brain Tumor | United States | Start date from 01/01/2020 to 06/24/2020
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Novel MRI Techniques for the Characterization and Treatment Assessment of High Grade Brain Lesions

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ClinicalTrials.gov Identifier: NCT04132843
Recruitment Status : Recruiting
First Posted : October 21, 2019
Last Update Posted : January 22, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Brain Neoplasm Malignant Brain Glioma Drug: Gadobenate Dimeglumine Drug: Gadobutrol Procedure: Magnetic Resonance Imaging Early Phase 1

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.

Study Design
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Study Type : Interventional
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Novel Multi-Parameter Mapping and Analysis Techniques for Characterization and Treatment Assessment of High Grade Brain Lesions
Actual Study Start Date : January 10, 2020
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : June 1, 2020

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Diagnostic (MRI, gadobutrol, gadobenate dimeglumine)
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
Given IV
Other Names:
  • Gd-BOPTA
  • MultiHance

Drug: Gadobutrol
Given IV
Other Names:
  • BAY86-4875
  • Gadavist
  • Gadograf
  • Gadovist
  • Protovis
  • ZK 135079

Procedure: Magnetic Resonance Imaging
Undergo MRI
Other Names:
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MR Imaging
  • MRI
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging


Outcome Measures
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Primary Outcome Measures :
  1. Differences in T2 spin parameters [ Time Frame: Baseline ]
    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.

  2. Differences between peritumoral and normal brain [ Time Frame: Baseline up to 120 days ]
    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 :
  1. Usefulness of T2 values in distinguishing non-enhancing components of the tumor [ Time Frame: Up to 120 days ]
    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.

  2. Quantification of T1 and proton density (PD) parameters [ Time Frame: Baseline up to 120 days ]
    Will quantify T1 and PD spin parameters of the peritumoral area and their differences before and after treatment.

  3. Post-contract T1 spin parameters with perfusion characteristics [ Time Frame: Up to 120 days ]
    Will examine post-contrast T1 spin parameters with perfusion characteristics as measured by an established dynamic susceptibility contrast technique.

  4. Differences in measured perfusion parameters between pre treatment and post treatment [ Time Frame: Baseline up to 120 days ]
    Will examine differences in measured perfusion parameters before and after treatment.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04132843


Contacts
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Contact: Linda Chi 713-745-0567 linda.chi@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Linda Chi    713-745-0567      
Principal Investigator: Linda Chi         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Linda Chi M.D. Anderson Cancer Center
More Information
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Additional Information:

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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT04132843    
Other Study ID Numbers: 2019-0324
NCI-2019-05781 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2019-0324 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: October 21, 2019    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
 Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases