Central Nervous System Neoplasm, Glioma, Metastatic Malignant Neoplasm in the Central Nervous System, Metastatic Malignant Solid Neoplasm
Conditions
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.
Interventions
PROCEDURE7 Tesla Magnetic Resonance Imaging
Undergo 7T MRI
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
National Cancer Institute (NCI)
M.D. Anderson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Contrast-to-noise Ratio (CNR) | 1 year | 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. |
Countries
United States
Participant flow
Recruitment details
Patients 13 years old and above with newly identified and untreated primary brain tumor or metastasis of at least 5 mm or greater in size. Up to twenty (20) healthy volunteers will be studied for the purposes of MRI sequence optimization
Participants by arm
| Arm | Count |
|---|---|
| Group 1 Healthy Volunteers | 8 |
| Group 2 Patients (13 years old and above) | 30 |
| Total | 38 |
Baseline characteristics
| Characteristic | Group 1 | Group 2 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 6 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 24 Participants | 32 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) White | 5 Participants | 27 Participants | 32 Participants |
| Region of Enrollment United States | 8 participants | 30 participants | 38 participants |
| Sex: Female, Male Female | 5 Participants | 18 Participants | 23 Participants |
| Sex: Female, Male Male | 3 Participants | 12 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 30 |
| other Total, other adverse events | 0 / 8 | 0 / 30 |
| serious Total, serious adverse events | 0 / 8 | 0 / 30 |
Outcome results
Primary
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.
Time frame: 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | Contrast-to-noise Ratio (CNR) | 60.6 contrast-to-noise ratio | Standard Deviation 26.6 |
| Group 2 | Contrast-to-noise Ratio (CNR) | 58.4 contrast-to-noise ratio | Standard Deviation 28 |