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

M.D. Anderson Cancer Center

Status: Completed

Conditions: Recurrent Malignant Brain Neoplasm; Metastatic Malignant Neoplasm in the Brain; Brain Neoplasm; Lymphoma

Treatments: Procedure: Magnetic Resonance Imaging; Drug: Gadobutrol; Drug: Gadobenate Dimeglumine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04132843

2019-0324 (Other Identifier)

NCI-2019-05781 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

6 participants in 1 patient group

Diagnostic (MRI, gadobutrol, gadobenate dimeglumine)

Experimental group

Description:

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.

Treatment:

Drug: Gadobenate Dimeglumine

Drug: Gadobutrol

Procedure: Magnetic Resonance Imaging