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

NCT04539574 | Completed Results FDA Device

• 2 other identifiers: 2019-1032NCI-2020-06374
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Diagnostic (7T MRI)

EXPERIMENTAL

Patients undergo 7T MRI over 60 minutes.

Procedure: 7 Tesla Magnetic Resonance Imaging; Other: Questionnaire Administration

Interventions

7 Tesla Magnetic Resonance Imaging PROCEDURE

Undergo 7T MRI

Also known as: 7 Tesla MRI, 7T MRI

Diagnostic (7T MRI)

Questionnaire Administration OTHER

Ancillary studies

Diagnostic (7T MRI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Central Nervous System Neoplasms; Glioma; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Max Wintermark, MD
• Organization: M.D. Anderson Cancer Center

mwintermark@mdanderson.org

713-792-0845

Study Officials

• Max Wintermark

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2020
• First Posted: September 7, 2020
• Study Start: September 4, 2020
• Primary Completion: April 26, 2024
• Study Completion: April 26, 2024
• Last Updated: January 8, 2025
• Results First Posted: January 8, 2025

Record last verified: 2024-12

Locations

US (1)