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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.
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
History of Changes
  Purpose

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).


Condition Intervention
Multiple Myeloma
 Other: ACT PET/CT

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: C11-Acetate PET/CT in Multiple Myeloma: Added Value to F18-Fluorodeoxyglucose PET/CT for Staging and Response Assessment

Resource links provided by NLM:

MedlinePlus related topics: Multiple Myeloma
U.S. FDA Resources

Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • 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)


Estimated Enrollment: 30
Study Start Date: May 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ACT PET/CT
Dual-tracer ACT/FDG PET/CT and WB-DCE-MRI at baseline (pretreatment), post-induction and post-ASCT (if eligible)
 Other: ACT PET/CT
Old tracer but new indication

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01691300

Locations
Taiwan
Chang Gung Memorial Hostpial Recruiting
Gueishan, Taoyuan county, Taiwan, 33305
Contact: Chieh Lin, MD, PhD     +886 3 3281200 ext 3594     sophieclin@gmail.com    
Principal Investigator: Chieh Lin, MD, PhD            
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Principal Investigator: Chieh Lin, MD, PhD Department of Molecular Imaging Center and Nuclear Medicine, Chang Gung Memorial Hospital
  More Information

No publications provided

Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01691300     History of Changes
Other Study ID Numbers: 99-2177A
Study First Received: September 20, 2012
Last Updated: September 27, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by Chang Gung Memorial Hospital:
C11-acetate PET/CT
Multiple myeloma
Pretreatment staging
Response assessment

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
 Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on May 19, 2013