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NCT01237054 · FLOW

Participant flow

Imaging in MGUS, SMM and MM · Source last updated 2026-02-06

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups
  1. 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
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      imaging 10C0096
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        31
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        30
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      type
      NOT COMPLETED
    title
    Overall Study
Complete source fields
groups
  1. 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
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      imaging 10C0096
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        31
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        30
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      type
      NOT COMPLETED
    title
    Overall Study

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Preserved source evidence · Not medical advice