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

November 11, 2015 updated by: Chang Gung Memorial Hospital

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pretreatment lesion detection
Time Frame: Within 2 weeks before initiation of therapy
Reference standards: bone marrow examination and whole-body dynamic contrast-enhanced MRI
Within 2 weeks before initiation of therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Approximately 4 months after initiation of therapy depending on the regimen
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
Approximately 3 months after ASCT

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
With 2 years of follow-up time

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Principal Investigator: Chieh Lin, MD, PhD, Department of Molecular Imaging Center and Nuclear Medicine, Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

September 20, 2012

First Submitted That Met QC Criteria

September 20, 2012

First Posted (Estimate)

September 24, 2012

Study Record Updates

Last Update Posted (Estimate)

November 13, 2015

Last Update Submitted That Met QC Criteria

November 11, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 99-2177A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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