N/A
N=38
An Investigational Scan (7T MRI) for the Imaging of Central Nervous System Tumors
Central Nervous System Neoplasm · Glioma · Metastatic Malignant Neoplasm in the Central Nervous System · Metastatic Malignant Solid Neoplasm
Bottom Line
View on ClinicalTrials.gov: NCT04539574 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Contrast-to-noise Ratio (CNR) — 60.6; 58.4 contrast-to-noise ratio
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 7 Tesla Magnetic Resonance Imaging (Procedure); Questionnaire Administration (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Contrast-to-noise Ratio (CNR) |
60.6; 58.4 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT04539574). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.