Spinal Cord Neoplasm
Conditions
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.
Interventions
DRUGFludeoxyglucose F-18
Given IV
DEVICEMagnetic Resonance Imaging
Undergo PET-MRI
PROCEDUREPositron Emission Tomography
Undergo PET-MRI
Sponsors
National Cancer Institute (NCI)
M.D. Anderson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Standard uptake value (SUV) max | Up to 8 hours | Identifying the specific malignancy |
| Lesion to background (L/B) ratio | 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 | 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. |
Countries
United States
Outcome results
None listed