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

Validation of a Multi-Parametric Ultra-High Field MRI Protocol for Central Nervous System Malignancy

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.

Study Overview

• Status: Completed
• Conditions: Glioma; Metastatic Malignant Solid Neoplasm; Central Nervous System Neoplasm; Metastatic Malignant Neoplasm in the Central Nervous System
• Intervention / Treatment: Other: Questionnaire Administration; Procedure: 7 Tesla Magnetic Resonance Imaging

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult patients must meet one set of 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diagnostic (7T MRI); Patients undergo 7T MRI over 60 minutes.	Other: Questionnaire Administration; Ancillary studies; Procedure: 7 Tesla Magnetic Resonance Imaging; Undergo 7T MRI; Other Names: 7T MRI; 7 Tesla MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contrast-to-noise Ratio (CNR)	Contrast-to-noise ratio (CNR) refers to the difference in signal intensity between the tumor and surrounding tissue. Higher CNR values indicate better image quality.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Conspicuity of each imaging modality to differentiate radiation necrosis from progressive disease	The T1 sequence by MRI will be considered the gold standard, and will compare the conspicuity of each of the other methods to that of T1 sequencing by using McNemar's test. This analysis will first be performed in the largest lesion per patient, and then analyses will be repeated using all lesions.	After completion of magnetic resonance imaging (MRI)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional (f)MRI paradigms	Will be summarized by the group mean and standard deviation.	After completion of MRI
Patient satisfaction	Will be reported on a five-point Likert scale and compared between the 7 Tesla (7T) scan and the most recent clinical scan by using a Wilcoxon rank-sum test.	1 year

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Max Wintermark, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2020
• Primary Completion (Actual): April 26, 2024
• Study Completion (Actual): April 26, 2024

Study Registration Dates

• First Submitted: August 31, 2020
• First Submitted That Met QC Criteria: August 31, 2020
• First Posted (Actual): September 7, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 27, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms by Site; Neoplasms; Nervous System Neoplasms; Central Nervous System Neoplasms
• Other Study ID Numbers: 2019-1032 (Other Identifier: M D Anderson Cancer Center); NCI-2020-06374 (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: Yes