Novel MRI Techniques for the Characterization and Treatment Assessment of High Grade Brain Lesions

November 15, 2022 updated by: M.D. Anderson Cancer Center

Novel Multi-Parameter Mapping and Analysis Techniques for Characterization and Treatment Assessment of High Grade Brain Lesions

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • M D Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.
Procedure: Magnetic Resonance Imaging
Undergo MRI
Other Names:
  • MRI
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MR
  • MR Imaging
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging
Drug: Gadobutrol
Given IV
Other Names:
  • BAY86-4875
  • Gadavist
  • Gadograf
  • Gadovist
  • Protovis
  • ZK 135079
Drug: Gadobenate Dimeglumine
Given IV
Other Names:
  • Gd-BOPTA
  • MultiHance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline
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.
Baseline up to 120 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 120 days
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.
Baseline up to 120 days
Post-contrast 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.
Up to 120 days
Differences in measured perfusion parameters before and after treatment.
Time Frame: Baseline up to 120 days
Will examine differences in measured perfusion parameters before and after treatment.
Baseline up to 120 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Ken-Pin Hwang, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2020

Primary Completion (Actual)

September 1, 2022

Study Completion (Actual)

September 1, 2022

Study Registration Dates

First Submitted

September 5, 2019

First Submitted That Met QC Criteria

October 16, 2019

First Posted (Actual)

October 21, 2019

Study Record Updates

Last Update Posted (Actual)

November 21, 2022

Last Update Submitted That Met QC Criteria

November 15, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-0324 (Other Identifier: M D Anderson Cancer Center)
  • NCI-2019-05781 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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