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C11-Acetate PET/CT in Multiple Myeloma: Added Value to F18-Fluorodeoxyglucose PET/CT (ACTMM)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Chang Gung Memorial Hospital
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01691300
First received: September 20, 2012
Last updated: September 27, 2012
Last verified: September 2012

September 20, 2012
September 27, 2012
May 2011
December 2013   (final data collection date for primary outcome measure)
Pretreatment lesion detection [ Time Frame: Within 2 weeks before initiation of therapy ] [ Designated as safety issue: No ]
Reference standards: bone marrow examination and whole-body dynamic contrast-enhanced MRI
Same as current
Complete list of historical versions of study NCT01691300 on ClinicalTrials.gov Archive Site
  • Post-induction response assessment [ Time Frame: Approximately 4 months after initiation of therapy depending on the regimen ] [ Designated as safety issue: No ]
    Reference standard: clinical response based on International Uniform Criteria and bone marrow examination if any
  • Post-ASCT response assessment [ Time Frame: Approximately 3 months after ASCT ] [ Designated as safety issue: No ]
    Reference standard: clinical response based on International Uniform Criteria and bone marrow examination if any
Post-induction and Post-ASCT response assessment [ Time Frame: Approximately 4 months after initiation of therapy and 3 months after the ASCT ] [ Designated as safety issue: No ]
Reference standard: clinical response based on International Uniform Criteria and bone marrow examination if any
Progression free survival [ Time Frame: With 2 years of follow-up time ] [ Designated as safety issue: No ]
Based on clinical follow-up (M-protein or FLC assay, bone marrow examination or imaging findings)
Same as current
 
C11-Acetate PET/CT in Multiple Myeloma: Added Value to F18-Fluorodeoxyglucose PET/CT
C11-Acetate PET/CT in Multiple Myeloma: Added Value to F18-Fluorodeoxyglucose PET/CT for Staging and Response Assessment

Positron emission tomography combined with computed tomography using carbon-11 acetate (ACT PET/CT) may help detect lesions before treatment and evaluate response following therapy in patients with from multiple myeloma (MM). This study aimed to prospectively assess the clinical utility of ACT PET/CT in MM as compared to the commonly used F18-fluorodeoxyglucose(FDG).

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Multiple Myeloma
Other: ACT PET/CT
Old tracer but new indication
Experimental: ACT PET/CT
Dual-tracer ACT/FDG PET/CT and WB-DCE-MRI at baseline (pretreatment), post-induction and post-ASCT (if eligible)
Intervention: Other: ACT PET/CT
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
December 2015
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • at least 20 years of age
  • previously untreated
  • complete pre-treatment clinical staging including bone marrow examination
  • written informed consent to participate in the study

Exclusion Criteria:

  • concurrent active malignant tumor(s)
  • pregnant or breast feeding women
  • non-compliant to PET/CT or to MRI
  • marked renal impairment (contraindicated for contrast-enhanced MRI)
Both
20 Years and older
No
Taiwan
 
NCT01691300
99-2177A
Yes
Chang Gung Memorial Hospital
Chang Gung Memorial Hospital
Not Provided
Principal Investigator: Chieh Lin, MD, PhD Department of Molecular Imaging Center and Nuclear Medicine, Chang Gung Memorial Hospital
Chang Gung Memorial Hospital
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP