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.
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
|Contact: Maria K. Gule-Monroefirstname.lastname@example.org|
|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|