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FDG PET-MRI for the Diagnosis of Spinal Cord Lesions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04219969
Recruitment Status : Recruiting
First Posted : January 7, 2020
Last Update Posted : January 7, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Tracking Information
First Submitted Date  ICMJE December 30, 2019
First Posted Date  ICMJE January 7, 2020
Last Update Posted Date January 7, 2020
Actual Study Start Date  ICMJE September 21, 2018
Estimated Primary Completion Date February 28, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 4, 2020)
  • Standard uptake value (SUV) max [ Time Frame: Up to 8 hours ]
    Identifying the specific malignancy
  • Lesion to background (L/B) ratio [ Time Frame: Up to 8 hours ]
    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 [ Time Frame: Up to 8 hours ]
    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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE FDG PET-MRI for the Diagnosis of Spinal Cord Lesions
Official Title  ICMJE Ideal Imaging Time Point Assessment for Spinal Cord Lesions of Unknown Etiology With FDG PET-MRI
Brief Summary This trial studies the best time point of using F18-FDG that gives the best image on PET-MRI in patients with spinal cord lesions of unknown cause. Diagnostic procedures, such as F18-FDG PET-MRI, may help find and diagnose spinal cord lesions.
Detailed Description

PRIMARY OBJECTIVES:

I. To identify the optimal imaging time point using fludeoxyglucose F-18 (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:

I. 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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Spinal Cord Neoplasm
Intervention  ICMJE
  • Other: Fludeoxyglucose F-18
    Given IV
    Other Names:
    • 18FDG
    • FDG
    • Fludeoxyglucose (18F)
    • fludeoxyglucose F 18
    • Fludeoxyglucose F18
    • Fluorine-18 2-Fluoro-2-deoxy-D-Glucose
    • Fluorodeoxyglucose F18
  • Procedure: Magnetic Resonance Imaging
    Undergo PET-MRI
    Other Names:
    • Magnetic Resonance Imaging Scan
    • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
    • MR Imaging
    • MRI
    • MRI Scan
    • NMR Imaging
    • NMRI
    • nuclear magnetic resonance imaging
  • Procedure: Positron Emission Tomography
    Undergo PET-MRI
    Other Names:
    • Medical Imaging, Positron Emission Tomography
    • PET
    • PET scan
    • Positron Emission Tomography Scan
    • Positron-Emission Tomography
    • proton magnetic resonance spectroscopic imaging
Study Arms  ICMJE Experimental: Diagnostic (18F-FDG PET-MRI)
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.
Interventions:
  • Other: Fludeoxyglucose F-18
  • Procedure: Magnetic Resonance Imaging
  • Procedure: Positron Emission Tomography
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: January 4, 2020)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 28, 2021
Estimated Primary Completion Date February 28, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
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: Maria K. Gule-Monroe 281-546-7750 mgule@mdanderson.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04219969
Other Study ID Numbers  ICMJE 2018-0144
NCI-2019-08224 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2018-0144 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
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: No
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: Maria K Gule-Monroe M.D. Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date January 2020

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