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

Not Applicable

Completed

• Conditions: Multiple Myeloma
• Interventions: Other: ACT PET/CT

• Registration Number: NCT01691300
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2012-09-20
• Study First Submitted QC: 2012-09-20
• Study First Posted: 2012-09-24
• Primary Completion: 2015-05
• Status Verified: 2015-11
• Study Completion: 2015-11
• Last Update Submitted: 2015-11-11
• Last Update Posted: 2015-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ACT PET/CT	ACT PET/CT	Dual-tracer ACT/FDG PET/CT and WB-DCE-MRI at baseline (pretreatment), post-induction and post-ASCT (if eligible)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Post-ASCT response assessment	Approximately 3 months after ASCT	Reference standard: clinical response based on International Uniform Criteria and bone marrow examination if any
Post-induction response assessment	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

Trial Locations

Locations (1)

Chang Gung Memorial Hostpial; 🇨🇳 Gueishan, Taoyuan county, Taiwan