search
Back to results

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

Primary Purpose

Central Nervous System Neoplasm, Glioma, Metastatic Malignant Neoplasm in the Central Nervous System

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
7 Tesla Magnetic Resonance Imaging
Questionnaire Administration
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Central Nervous System Neoplasm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • M D Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (7T MRI)

Arm Description

Patients undergo 7T MRI over 60 minutes.

Outcomes

Primary Outcome Measures

Contrast-to-noise ratio (CNR)
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.

Secondary Outcome Measures

Conspicuity of each imaging modality to differentiate radiation necrosis from progressive disease
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.

Full Information

First Posted
August 31, 2020
Last Updated
September 22, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT04539574
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 4, 2020 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Nervous System Neoplasm, Glioma, Metastatic Malignant Neoplasm in the Central Nervous System, Metastatic Malignant Solid Neoplasm

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (7T MRI)
Arm Type
Experimental
Arm Description
Patients undergo 7T MRI over 60 minutes.
Intervention Type
Procedure
Intervention Name(s)
7 Tesla Magnetic Resonance Imaging
Other Intervention Name(s)
7 Tesla MRI, 7T MRI
Intervention Description
Undergo 7T MRI
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Contrast-to-noise ratio (CNR)
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Conspicuity of each imaging modality to differentiate radiation necrosis from progressive disease
Description
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.
Time Frame
After completion of magnetic resonance imaging (MRI)
Other Pre-specified Outcome Measures:
Title
Functional (f)MRI paradigms
Description
Will be summarized by the group mean and standard deviation.
Time Frame
After completion of MRI
Title
Patient satisfaction
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Max Wintermark
Phone
713-792-0845
Email
mwintermark@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Max Wintermark
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Max Wintermark
Phone
713-792-0485
Email
mwintermark@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Max Wintermark

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center Website

Learn more about this trial

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

We'll reach out to this number within 24 hrs