Back to resultsC11-Acetate PET/CT in Multiple Myeloma: Added Value to F18-Fluorodeoxyglucose PET/CT (ACTMM)
Primary Purpose
Multiple Myeloma
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
ACT PET/CT
Sponsored by
About this trial
This is an interventional diagnostic trial for Multiple Myeloma focused on measuring C11-acetate PET/CT, Multiple myeloma, Pretreatment staging, Response assessment
Eligibility 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)
Sites / Locations
- Chang Gung Memorial Hostpial
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ACT PET/CT
Arm Description
Dual-tracer ACT/FDG PET/CT and WB-DCE-MRI at baseline (pretreatment), post-induction and post-ASCT (if eligible)
Outcomes
Primary Outcome Measures
Pretreatment lesion detection
Reference standards: bone marrow examination and whole-body dynamic contrast-enhanced MRI
Secondary Outcome Measures
Post-induction response assessment
Reference standard: clinical response based on International Uniform Criteria and bone marrow examination if any
Post-ASCT response assessment
Reference standard: clinical response based on International Uniform Criteria and bone marrow examination if any
Full Information
NCT ID
NCT01691300
First Posted
September 20, 2012
Last Updated
November 11, 2015
Sponsor
Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01691300
Brief Title
C11-Acetate PET/CT in Multiple Myeloma: Added Value to F18-Fluorodeoxyglucose PET/CT
Acronym
ACTMM
Official Title
C11-Acetate PET/CT in Multiple Myeloma: Added Value to F18-Fluorodeoxyglucose PET/CT for Staging and Response Assessment
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
C11-acetate PET/CT, Multiple myeloma, Pretreatment staging, Response assessment
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ACT PET/CT
Arm Type
Experimental
Arm Description
Dual-tracer ACT/FDG PET/CT and WB-DCE-MRI at baseline (pretreatment), post-induction and post-ASCT (if eligible)
Intervention Type
Other
Intervention Name(s)
ACT PET/CT
Intervention Description
Old tracer but new indication
Primary Outcome Measure Information:
Title
Pretreatment lesion detection
Description
Reference standards: bone marrow examination and whole-body dynamic contrast-enhanced MRI
Time Frame
Within 2 weeks before initiation of therapy
Secondary Outcome Measure Information:
Title
Post-induction response assessment
Description
Reference standard: clinical response based on International Uniform Criteria and bone marrow examination if any
Time Frame
Approximately 4 months after initiation of therapy depending on the regimen
Title
Post-ASCT response assessment
Description
Reference standard: clinical response based on International Uniform Criteria and bone marrow examination if any
Time Frame
Approximately 3 months after ASCT
Other Pre-specified Outcome Measures:
Title
Progression free survival
Description
Based on clinical follow-up (M-protein or FLC assay, bone marrow examination or imaging findings)
Time Frame
With 2 years of follow-up time
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chieh Lin, MD, PhD
Organizational Affiliation
Department of Molecular Imaging Center and Nuclear Medicine, Chang Gung Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chang Gung Memorial Hostpial
City
Gueishan
State/Province
Taoyuan county
ZIP/Postal Code
33305
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
C11-Acetate PET/CT in Multiple Myeloma: Added Value to F18-Fluorodeoxyglucose PET/CT
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