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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT04539574
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 M.D. Anderson Cancer Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Max Wintermark
Principal Investigator Affiliation M.D. Anderson Cancer Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, NIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Central Nervous System Neoplasm, Glioma, Metastatic Malignant Neoplasm in the Central Nervous System, Metastatic Malignant Solid Neoplasm
Study Website: View Trial Website
Additional Details

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.

Arms & Interventions

Arms

Experimental: Diagnostic (7T MRI)

Patients undergo 7T MRI over 60 minutes.

Interventions

Procedure: - 7 Tesla Magnetic Resonance Imaging

Undergo 7T MRI

Other: - Questionnaire Administration

Ancillary studies

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

M D Anderson Cancer Center, Houston, Texas

Status

Recruiting

Address

M D Anderson Cancer Center

Houston, Texas, 77030

Site Contact

Max Wintermark

[email protected]

713-792-0485

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