FDG PET-MRI for the Diagnosis of Spinal Cord Lesions
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|ClinicalTrials.gov Identifier: NCT04219969|
Recruitment Status : Recruiting
First Posted : January 7, 2020
Last Update Posted : January 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Neoplasm||Other: Fludeoxyglucose F-18 Procedure: Magnetic Resonance Imaging Procedure: Positron Emission Tomography||Not Applicable|
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.
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.
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 (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
Procedure: Magnetic Resonance Imaging
Procedure: Positron Emission Tomography
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04219969
|Contact: Maria K. Gule-Monroeemail@example.com|
|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|
|Principal Investigator:||Maria K Gule-Monroe||M.D. Anderson Cancer Center|