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

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ClinicalTrials.gov Identifier: NCT04539574
Recruitment Status : Recruiting
First Posted : September 7, 2020
Last Update Posted : February 8, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Tracking Information
First Submitted Date  ICMJE August 31, 2020
First Posted Date  ICMJE September 7, 2020
Last Update Posted Date February 8, 2021
Actual Study Start Date  ICMJE September 4, 2020
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 31, 2020)
Contrast-to-noise ratio (CNR) [ Time Frame: 1 year ]
For each imaging modality, will calculate the CNR separately in the largest lesion/metastasis per patient as well as in all study lesions. The CNR for each imaging method will be determined and reported along with the corresponding 95% confidence interval. If enough follow-up images are obtained, will compare the CNR in lesions that respond to treatment to those that do not by using a Wilcoxon rank-sum test. Will compare the CNR between baseline and follow-up within patient by using a Wilcoxon signed-rank test. Also, for those lesions that initially respond, some will subsequently grow in size after the initial response. Of these, some will be considered radiation necrosis and some progressive disease. The CNR will be compared between lesions with necrosis and those that are progressive disease using a Wilcoxon rank-sum test.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2020)
Conspicuity of each imaging modality to differentiate radiation necrosis from progressive disease [ Time Frame: After completion of magnetic resonance imaging (MRI) ]
The T1 sequence by MRI will be considered the gold standard, and will compare the conspicuity of each of the other methods to that of T1 sequencing by using McNemar's test. This analysis will first be performed in the largest lesion per patient, and then analyses will be repeated using all lesions.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 31, 2020)
  • Functional (f)MRI paradigms [ Time Frame: After completion of MRI ]
    Will be summarized by the group mean and standard deviation.
  • Patient satisfaction [ Time Frame: 1 year ]
    Will be reported on a five-point Likert scale and compared between the 7 Tesla (7T) scan and the most recent clinical scan by using a Wilcoxon rank-sum test.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE An Investigational Scan (7T MRI) for the Imaging of Central Nervous System Tumors
Official Title  ICMJE Validation of a Multi-Parametric Ultra-High Field MRI Protocol for Central Nervous System Malignancy
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Central Nervous System Neoplasm
  • Glioma
  • Metastatic Malignant Neoplasm in the Central Nervous System
  • Metastatic Malignant Solid Neoplasm
Intervention  ICMJE
  • Procedure: 7 Tesla Magnetic Resonance Imaging
    Undergo 7T MRI
    Other Names:
    • 7 Tesla MRI
    • 7T MRI
  • Other: Questionnaire Administration
    Ancillary studies
Study Arms  ICMJE Experimental: Diagnostic (7T MRI)
Patients undergo 7T MRI over 60 minutes.
Interventions:
  • Procedure: 7 Tesla Magnetic Resonance Imaging
  • Other: Questionnaire Administration
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 31, 2020)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jason Johnson 713-792-8443 jjohnson12@mdanderson.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04539574
Other Study ID Numbers  ICMJE 2019-1032
NCI-2020-06374 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2019-1032 ( Other Identifier: M D Anderson Cancer Center )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party M.D. Anderson Cancer Center
Study Sponsor  ICMJE M.D. Anderson Cancer Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Jason Johnson M.D. Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP