FDG PET-MRI for the Diagnosis of Spinal Cord Lesions

Study Overview
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Brief Summary
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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
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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.

Official Title
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Ideal Imaging Time Point Assessment for Spinal Cord Lesions of Unknown Etiology With FDG PET-MRI

Conditions
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Spinal Cord Neoplasm

Intervention / Treatment
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* Drug: Fludeoxyglucose F-18
* Device: Magnetic Resonance Imaging
* Procedure: Positron Emission Tomography


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (18F-FDG PET-MRI)<br>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. | Drug: Fludeoxyglucose F-18<br>* Given IV<br>* Other names: Fluorodeoxyglucose F18;Device: Magnetic Resonance Imaging<br>* Undergo PET-MRI<br>* Other names: nuclear magnetic resonance imaging;Procedure: Positron Emission Tomography<br>* Undergo PET-MRI<br>* Other names: proton magnetic resonance spectroscopic imaging;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standard uptake value (SUV) max | Identifying the specific malignancy | Up to 8 hours | 
| 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. | Up to 8 hours | 
| 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. | Up to 8 hours |