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

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ClinicalTrials.gov Identifier: NCT01691300
Recruitment Status : Completed
First Posted : September 24, 2012
Last Update Posted : November 13, 2015
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

Brief Summary:
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 or disease Intervention/treatment
Multiple Myeloma Other: ACT PET/CT

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : May 2011
Primary Completion Date : May 2015
Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 :
  1. 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

  2. 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:
  1. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01691300


Locations
Taiwan
Chang Gung Memorial Hostpial
Gueishan, Taoyuan county, Taiwan, 33305
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

Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01691300     History of Changes
Other Study ID Numbers: 99-2177A
First Posted: September 24, 2012    Key Record Dates
Last Update Posted: November 13, 2015
Last Verified: November 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
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action