An Investigational Scan (7T MRI) for the Imaging of Central Nervous System Tumors

NCT ID: NCT04539574

Last Updated: 2025-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-04
• Study Completion Date: 2024-04-26

Brief Summary

This trial investigates how well 7T MRI scan works in imaging central nervous system tumors. Diagnostic procedures, such as 7T MRI, may help find and diagnose central nervous system tumors and help measure a patient's response to earlier treatment. The goal of this trial is to learn if a new MRI system can provide better quality images than a standard MRI.

Detailed Description

PRIMARY OBJECTIVE:

I. To estimate the contrast-to-noise ratio (CNR) for several imaging modalities in brain malignancy as compared with normal brain parenchyma separately by type of malignancy and treatment status.

SECONDARY OBJECTIVE:

I. To assess the conspicuity of each imaging modality to differentiate radiation necrosis from progressive disease.

EXPLORATORY OBJECTIVES:

I. To assess patient experience in the 7 Tesla (7T) magnetic resonance imaging (MRI) system compared to their most recent MRI examination.

II. To assess the typical significance values seen for areas of maximal brain activity associated with each functional MRI (fMRI) test.

III. To assess the geometric distortion of a radiation planning sequence on a ultra-high field (UHF) system.

OUTLINE:

Patients undergo 7T MRI over 60 minutes.

Conditions

Central Nervous System Neoplasm; Glioma; Metastatic Malignant Neoplasm in the Central Nervous System; Metastatic Malignant Solid Neoplasm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Diagnostic (7T MRI)

Patients undergo 7T MRI over 60 minutes.

Group Type: EXPERIMENTAL

7 Tesla Magnetic Resonance Imaging

Intervention Type: PROCEDURE

Undergo 7T MRI

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Interventions

7 Tesla Magnetic Resonance Imaging

Undergo 7T MRI

Intervention Type: PROCEDURE

Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

Other Intervention Names

7 Tesla MRI; 7T MRI

Eligibility Criteria

Inclusion Criteria

• Newly identified and untreated central nervous system glioma or metastasis of at least 5 mm or greater in size

• Suspected central nervous system neoplasms will require agreement from a study neuroradiologist and a study neurosurgeon or a radiation oncology that a lesion exists that is most likely either a glioma or a metastasis
• Patients with suspected brain metastasis must also have a history of solid organ malignancy
• History of central nervous system glioma or metastasis treated with surgery, radiation, chemotherapy, or immunotherapy with new or increasing signal on MR imaging that is suspicious for progressive disease (treatment failure)

• Suspected recurrent neoplasms will require agreement from a study neuroradiologist and a study neurosurgeon, radiation oncologist, or neuro-oncologist that lesion behavior is suspicious for recurrent disease

Exclusion Criteria

• Contraindication to MR imaging
• Absolute or relative contra-indication to 3T MRI due to metallic foreign bodies and devices and/or other conditions that are not MR safe, which include implants with unknown behavior in 3T MRI as well as:

• Electronically, magnetically, and mechanically activated implants
• Ferromagnetic or electronically operated active devices like automatic cardioverter defibrillators and cardiac pacemakers
• Metallic splinters in the eye
• Ferromagnetic hemostatic clips in the central nervous system (CNS) or body
• Cochlear implants
• Other pacemakers, e.g., for the carotid sinus
• Insulin pumps and nerve stimulators
• Non-MR safe lead wires
• Prosthetic heart valves (if dehiscence is suspected)
• Non-ferromagnetic stapedial implants
• Pregnancy
• Claustrophobia that does not readily respond to oral medication
• Known allergy to gadolinium-based contrast agents
• Renal failure as defined by a glomerular filtration rate (GFR) less than 30 or the use of hemodialysis
• Pregnant
• Interval treatment with radiation or surgery between the diagnostic MRI lesion identification and planned study MRI

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Max Wintermark

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

M D Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

http://www.mdanderson.org

MD Anderson Cancer Center Website

Other Identifiers

NCI-2020-06374

Identifier Type: REGISTRY

Identifier Source: secondary_id

2019-1032

Identifier Type: OTHER

Identifier Source: secondary_id

2019-1032

Identifier Type: -

Identifier Source: org_study_id