FDG PET-MRI for the Diagnosis of Spinal Cord Lesions

N/ACompletedNCT04219969

M.D. Anderson Cancer Center11 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Spinal Cord Neoplasm

Interventions

Fludeoxyglucose F-18DRUG

Given IV

Magnetic Resonance ImagingDEVICE

Undergo PET-MRI

Positron Emission TomographyPROCEDURE

Undergo PET-MRI

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

M D Anderson Cancer Center

Houston, Texas, United States

Outcomes

Primary Outcomes

Standard uptake value (SUV) max

Identifying the specific malignancy

Time frame: 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.

Time frame: 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.

Time frame: Up to 8 hours

Data from ClinicalTrials.gov

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