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Completed

NCT Number: NCT01691300

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

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).

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chang Gung Memorial Hostpial

Guishan, Taoyuan county, 33305, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

ACT PET/CT

Other

Old tracer but new indication

Primary outcomes

  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 outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

C11-Acetate PET/CT in Multiple Myeloma: Added Value to F18-Fluorodeoxyglucose PET/CT for Staging and Response Assessment

Acronym: ACTMM

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Sep 24, 2012
Registry last updated
Nov 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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