Combined 18F NaF/18F FDG PET/MRI for Detection of Skeletal Metastases
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|ClinicalTrials.gov Identifier: NCT00375830|
Recruitment Status : Recruiting
First Posted : September 13, 2006
Last Update Posted : April 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Procedure: Positron Emission Tomography Procedure: Magnetic Resonance Imaging Radiation: Fludeoxyglucose F-18 Radiation: Fluorine F 18 Sodium Fluoride||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||170 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Combined 18F NaF/18F FDG PET/MRI for Detection of Skeletal Metastases|
|Study Start Date :||January 2006|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2019|
Experimental: Diagnostic (18F NaF/18F FDG PET/MRI)
Patients undergo a combined 18F NaF and 18F FDG PET/MRI scan over 45 minutes.
Procedure: Positron Emission Tomography
Undergo 18F NaF PET/MRIProcedure: Magnetic Resonance Imaging
Undergo 18F NaF PET/MRIRadiation: Fludeoxyglucose F-18
105851-17-0, 18FDG, 2-Deoxy-2-(18F)Fluoro-D-Glucose, 2-F18-Fluoro-2-deoxy-D-glucose, 2-F18-Fluoro-2-deoxyglucose, 723398, FDG, fludeoxyglucose F 18, FLUDEOXYGLUCOSE F-18, Fludeoxyglucose F-18, Fludeoxyglucose F-18, Fludeoxyglucose F18, Fluorine-18 2-Fluoro-2-deoxy-D-Glucose, Fluorodeoxyglucose F18Radiation: Fluorine F 18 Sodium Fluoride
Undergo 18F NaF PET/MRI
- Concordance between 99mTc MDP bone scan and 18F NaF/18F FDG PET/MRI as the proportion of patients where the modalities agree [ Time Frame: 12 months ]Calculate the concordance between the modalities across outcomes (combining cases and controls) and evaluate the results by calculating the kappa coefficient.
- Concordance in cases and controls, sensitivity, specificity, positive predicted value, and negative predictive value (per patient) [ Time Frame: 12 months ]Calculated both as aggregates of the three diseases and separately by disease. Sensitivities and other summaries will only be calculated if they involve a denominator of at least 10.
- Distribution of lesions seen on each modality (per lesion) [ Time Frame: 12 months ]Calculated both as aggregates of the three diseases and separately by disease. Sensitivities and other summaries will only be calculated if they involve a denominator of at least 10.
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): NCT00375830
|United States, California|
|Stanford University School of Medicine||Recruiting|
|Stanford, California, United States, 94305|
|Contact: Risa Jiron 650-736-1598 firstname.lastname@example.org|
|Principal Investigator: Andrei Iagaru|
|Sub-Investigator: Eric Mittra|
|Sub-Investigator: Shreyas Vasanawala|
|Sub-Investigator: Robert Herfkens|
|Principal Investigator:||Andrei Iagaru, MD||Stanford University|