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

This study has been completed.
Information provided by (Responsible Party):
Chang Gung Memorial Hospital Identifier:
First received: September 20, 2012
Last updated: November 11, 2015
Last verified: November 2015
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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
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:

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 ]
    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 ]
    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 ]
    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 ]
    Based on clinical follow-up (M-protein or FLC assay, bone marrow examination or imaging findings)

Enrollment: 30
Study Start Date: May 2011
Study Completion Date: November 2015
Primary Completion Date: May 2015 (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)
Old tracer but new indication


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01691300

Chang Gung Memorial Hostpial
Gueishan, Taoyuan county, Taiwan, 33305
Sponsors and Collaborators
Chang Gung Memorial Hospital
Principal Investigator: Chieh Lin, MD, PhD Department of Molecular Imaging Center and Nuclear Medicine, Chang Gung Memorial Hospital
  More Information

Responsible Party: Chang Gung Memorial Hospital Identifier: NCT01691300     History of Changes
Other Study ID Numbers: 99-2177A
Study First Received: September 20, 2012
Last Updated: November 11, 2015

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
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases processed this record on May 24, 2017