FDG PET-MRI for the Diagnosis of Spinal Cord Lesions
Primary Purpose
Spinal Cord Neoplasm
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fludeoxyglucose F-18
Magnetic Resonance Imaging
Positron Emission Tomography
Sponsored by
About this trial
This is an interventional diagnostic trial for Spinal Cord Neoplasm
Eligibility Criteria
Inclusion Criteria:
- Patients with untreated intramedullary cord lesion(s)
- Ability to undergo FDG PET MR examination
Exclusion Criteria:
- No prior surgery or biopsy of the spinal cord
- No metal implanted in area of interest
- Spine radiation therapy
- Known allergy to FDG or gadolinium based contrast agents
- Blood glucose (> 200 mg/dl)
- Pregnant women are excluded
- Need for conscious sedation or anesthesia in order to tolerate study
Sites / Locations
- M D Anderson Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Diagnostic (18F-FDG PET-MRI)
Arm Description
Patients receive fludeoxyglucose F-18 IV over 1 minutes and then undergo PET-MRI over 15-60 minutes at 60, 300, and 480 minutes after fludeoxyglucose F-18 injection in the absence of unacceptable toxicity.
Outcomes
Primary Outcome Measures
Standard uptake value (SUV) max
Identifying the specific malignancy
Lesion to background (L/B) ratio
L is the lesion metric (mean, max, etc.) and B is the corresponding background metric. These values will be plotted versus time and the delayed time point corresponding to the highest value for each metric recorded. Differences in L/B ratio will be tested via paired t-test.
Optimal imaging time point
Defined as the time point by which there is the largest average SUVmax L/B ratio and significantly different from baseline at the 0.025 significance level.
Secondary Outcome Measures
Full Information
NCT ID
NCT04219969
First Posted
December 30, 2019
Last Updated
October 2, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT04219969
Brief Title
FDG PET-MRI for the Diagnosis of Spinal Cord Lesions
Official Title
Ideal Imaging Time Point Assessment for Spinal Cord Lesions of Unknown Etiology With FDG PET-MRI
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 21, 2018 (Actual)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
February 28, 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
To compare the results and understand the possible benefits from FDG-PET/MRI during different scanning time points after FDG, a type of contrast drug, is given.
Detailed Description
Primary Objectives:
--To identify the optimal imaging time point using F18-FDG positron emission tomography (PET) that gives the best lesion conspicuity as defined by the best lesion to background (L/B) ratio when evaluating spinal cord lesions of unknown etiology.
Exploratory Objectives:
To identify malignancy specific factors in F18-FDG metabolism derived from metrics such as maximum standard uptake value (SUVmax), mean standard uptake value (SUVmean), total lesion glycolysis (TLG), metabolic tumor volume (MTV) and L/B ratio.
To identify patterns of metabolism derived from metrics such as SUVmax, SUVmean, TLG, MTV, L/B ratio and magnetic resonance imaging metrics such as regional perfusion abnormalities, apparent diffusion coefficient values and mean diffusivity measures.
OUTLINE:
Patients receive fludeoxyglucose F-18 intravenously (IV) over 1 minutes and then undergo PET-magnetic resonance imaging (MRI) over 15-60 minutes at 60, 300, and 480 minutes after fludeoxyglucose F-18 injection in the absence of unacceptable toxicity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord 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
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Diagnostic (18F-FDG PET-MRI)
Arm Type
Experimental
Arm Description
Patients receive fludeoxyglucose F-18 IV over 1 minutes and then undergo PET-MRI over 15-60 minutes at 60, 300, and 480 minutes after fludeoxyglucose F-18 injection in the absence of unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
Fludeoxyglucose F-18
Other Intervention Name(s)
18FDG, FDG, Fludeoxyglucose (18F), fludeoxyglucose F 18, Fludeoxyglucose F18, Fluorine-18 2-Fluoro-2-deoxy-D-Glucose, Fluorodeoxyglucose F18
Intervention Description
Given IV
Intervention Type
Device
Intervention Name(s)
Magnetic Resonance Imaging
Other Intervention Name(s)
Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, nuclear magnetic resonance imaging
Intervention Description
Undergo PET-MRI
Intervention Type
Procedure
Intervention Name(s)
Positron Emission Tomography
Other Intervention Name(s)
Medical Imaging, Positron Emission Tomography, PET, PET scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging
Intervention Description
Undergo PET-MRI
Primary Outcome Measure Information:
Title
Standard uptake value (SUV) max
Description
Identifying the specific malignancy
Time Frame
Up to 8 hours
Title
Lesion to background (L/B) ratio
Description
L is the lesion metric (mean, max, etc.) and B is the corresponding background metric. These values will be plotted versus time and the delayed time point corresponding to the highest value for each metric recorded. Differences in L/B ratio will be tested via paired t-test.
Time Frame
Up to 8 hours
Title
Optimal imaging time point
Description
Defined as the time point by which there is the largest average SUVmax L/B ratio and significantly different from baseline at the 0.025 significance level.
Time Frame
Up to 8 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with untreated intramedullary cord lesion(s)
Ability to undergo FDG PET MR examination
Exclusion Criteria:
No prior surgery or biopsy of the spinal cord
No metal implanted in area of interest
Spine radiation therapy
Known allergy to FDG or gadolinium based contrast agents
Blood glucose (> 200 mg/dl)
Pregnant women are excluded
Children of less than 18 years of age
Need for conscious sedation or anesthesia in order to tolerate study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria K Gule-Monroe
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
12. IPD Sharing Statement
Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center
Learn more about this trial
FDG PET-MRI for the Diagnosis of Spinal Cord Lesions
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