NCT04132843

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Brain Neoplasm
• Lymphoma
• Metastatic Malignant Neoplasm in the Brain
• Recurrent Malignant Brain Neoplasm

Interventions

Type	Name	Description
DRUG	Gadobenate Dimeglumine	Given IV
DRUG	Gadobutrol	Given IV
PROCEDURE	Magnetic Resonance Imaging	Undergo MRI

Timeline

• Start date: 2020-01-10
• Primary completion: 2022-09-01
• Completion: 2022-09-01
• First posted: 2019-10-21
• Last updated: 2022-11-21

Locations

1 site across 1 country: United States