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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

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.

Condition or disease Intervention/treatment Phase
Spinal Cord Neoplasm Other: Fludeoxyglucose F-18 Procedure: Magnetic Resonance Imaging Procedure: Positron Emission Tomography Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Ideal Imaging Time Point Assessment for Spinal Cord Lesions of Unknown Etiology With FDG PET-MRI
Actual Study Start Date : September 21, 2018
Estimated Primary Completion Date : February 28, 2021
Estimated Study Completion Date : February 28, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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




Primary Outcome Measures :
  1. Standard uptake value (SUV) max [ Time Frame: Up to 8 hours ]
    Identifying the specific malignancy

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04219969


Contacts
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Contact: Maria K. Gule-Monroe 281-546-7750 mgule@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Maria K. Gule-Monroe    281-546-7750      
Principal Investigator: Maria K. Gule-Monroe         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Maria K Gule-Monroe M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT04219969    
Other Study ID Numbers: 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 )
First Posted: January 7, 2020    Key Record Dates
Last Update Posted: January 7, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spinal Cord Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action