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

M.D. Anderson Cancer Center

Status

Completed

Conditions

Glioma

Metastatic Malignant Solid Neoplasm

Metastatic Malignant Neoplasm in the Central Nervous System

Central Nervous System Neoplasm

Treatments

Procedure: 7 Tesla Magnetic Resonance Imaging

Other: Questionnaire Administration

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT04539574

2019-1032 (Other Identifier)

NCI-2020-06374 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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