NCT01237054 · FLOW
Participant flow
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- groups
- description
- Participants will have three imaging studies on separate days: a standard positron emission tomography/computed tomography scan (18-FDG PET/CT), a PET/CT scan with an experimental sodium fluoride-based drug (18-NaF PET/CT), and magnetic resonance imaging (DCE-MRI). 18-NaF PET: The patient will patient will receive 5mCi of F-18 NaF IV bolus, followed by a \~20 ml saline (sodium chloride IV infusion 0.9% w/v) flush over a period of \~20 seconds. Serial dynamic imaging (2 minutes/bed position) will be obtained over a 1-hour period. The patient will be permitted an imaging break until a static PET/CT is performed beginning at 2-hours post F-18 NaF injection. DCE-MRI: An FDA approved gadolinium chelate (e.g. Magnevist, Berlex Laboratories, NJ, USA) will be administered intravenously at 3 cc/sec using an automated pump injector (Medrad, Pittsburgh, PA, USA).18-FDG PET/CT: The 18F-FDG injection procedure will be injected and be followed by a \~20 ml saline flush over a period of \~20 sec.
- id
- FG000
- title
- Imaging in MGUS, SMM, and MM
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- imaging 10C0096
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 31
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 30
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 1
- type
- NOT COMPLETED
- title
- Overall Study
Complete source fields
- groups
- description
- Participants will have three imaging studies on separate days: a standard positron emission tomography/computed tomography scan (18-FDG PET/CT), a PET/CT scan with an experimental sodium fluoride-based drug (18-NaF PET/CT), and magnetic resonance imaging (DCE-MRI). 18-NaF PET: The patient will patient will receive 5mCi of F-18 NaF IV bolus, followed by a \~20 ml saline (sodium chloride IV infusion 0.9% w/v) flush over a period of \~20 seconds. Serial dynamic imaging (2 minutes/bed position) will be obtained over a 1-hour period. The patient will be permitted an imaging break until a static PET/CT is performed beginning at 2-hours post F-18 NaF injection. DCE-MRI: An FDA approved gadolinium chelate (e.g. Magnevist, Berlex Laboratories, NJ, USA) will be administered intravenously at 3 cc/sec using an automated pump injector (Medrad, Pittsburgh, PA, USA).18-FDG PET/CT: The 18F-FDG injection procedure will be injected and be followed by a \~20 ml saline flush over a period of \~20 sec.
- id
- FG000
- title
- Imaging in MGUS, SMM, and MM
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- imaging 10C0096
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 31
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 30
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 1
- type
- NOT COMPLETED
- title
- Overall Study
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