Clinical trial NCT04539574: An Investigational Scan (7T MRI) for the Imaging of Central Nervous System Tumors
Official title: Validation of a Multi-Parametric Ultra-High Field MRI Protocol for Central Nervous System Malignancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Central Nervous System Neoplasm
Glioma
Metastatic Malignant Neoplasm in the Central Nervous System
Metastatic Malignant Solid Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-09-07
Enrollment: 50
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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Contrast-to-noise Ratio (CNR)
timeFrame: 1 year
Secondary outcomes:
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: Max Wintermark
role: PRINCIPAL_INVESTIGATOR
References: