Imaging in MGUS, SMM and MM

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Peter Choyke, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01237054
First received: November 6, 2010
Last updated: October 5, 2015
Last verified: October 2015
Results First Received: December 18, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Conditions: Multiple Myeloma
Smoldering Multiple Myeloma
Monoclonal Gammopathy of Undetermined Significance
Interventions: Drug: 18-NaF PET
Other: DCE-MRI
Drug: 18-FDG PET/CT

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Imaging in MGUS, SMM, and MM

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.


Participant Flow:   Overall Study
    Imaging in MGUS, SMM, and MM  
STARTED     31  
COMPLETED     30  
NOT COMPLETED     1  
imaging 10C0096                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Imaging in MGUS, SMM, and MM

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.


Baseline Measures
    Imaging in MGUS, SMM, and MM  
Number of Participants  
[units: participants]
  31  
Age  
[units: years]
Mean (Standard Deviation)
  62.89  (10.58)  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     20  
>=65 years     11  
Gender  
[units: participants]
 
Female     18  
Male     13  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     1  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     4  
White     26  
More than one race     0  
Unknown or Not Reported     0  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     0  
Not Hispanic or Latino     31  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
United States     31  



  Outcome Measures
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1.  Primary:   Number of Participants With Positive and Negative 18F-FDG PET CT and F18-NaF PET CT Imaging Results in Individuals With MGUS, SMM, and MM.   [ Time Frame: 60 days ]

2.  Primary:   Number of Participants With Positive DCE-MRI Imaging Results   [ Time Frame: 60 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Peter Choyke
Organization: National Cancer Institute
phone: 301-402-8409
e-mail: pchoyke@mail.cc.nih.gov


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Peter Choyke, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT01237054     History of Changes
Other Study ID Numbers: 110020
11-C-0020
Study First Received: November 6, 2010
Results First Received: December 18, 2014
Last Updated: October 5, 2015
Health Authority: United States: Federal Government
United States: Food and Drug Administration