Clinical trial NCT04132843: Novel MRI Techniques for the Characterization and Treatment Assessment of High Grade Brain Lesions
Official title: Novel Multi-Parameter Mapping and Analysis Techniques for Characterization and Treatment Assessment of High Grade Brain Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Neoplasm
Lymphoma
Metastatic Malignant Neoplasm in the Brain
Recurrent Malignant Brain Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-10-21
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility 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 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

Primary outcomes:
measure: Differences in T2 spin parameters
timeFrame: Baseline
measure: Differences between peritumoral and normal brain
timeFrame: Baseline up to 120 days
Secondary outcomes:
measure: Usefulness of T2 values in distinguishing non-enhancing components of the tumor
timeFrame: Up to 120 days
measure: Quantification of T1 and proton density (PD) parameters
timeFrame: Baseline up to 120 days
measure: Post-contrast T1 spin parameters with perfusion characteristics
timeFrame: Up to 120 days
measure: Differences in measured perfusion parameters before and after treatment.
timeFrame: Baseline up to 120 days
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Ken-Pin Hwang, MD
role: PRINCIPAL_INVESTIGATOR
References: