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

Multiple Myeloma Clinical Trial

— ACTMM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01691300
• Other study ID #: 99-2177A
• Status: Completed
• Phase: N/A
• First received: September 20, 2012
• Last updated: November 11, 2015
• Start date: May 2011
• Est. completion date: November 2015

Study information

• Verified date: November 2015
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Other:
• ACT PET/CT
Old tracer but new indication

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hostpial	Gueishan	Taoyuan county

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Progression free survival	Based on clinical follow-up (M-protein or FLC assay, bone marrow examination or imaging findings)	With 2 years of follow-up time	No
Primary	Pretreatment lesion detection	Reference standards: bone marrow examination and whole-body dynamic contrast-enhanced MRI	Within 2 weeks before initiation of therapy	No
Secondary	Post-induction response assessment	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	No
Secondary	Post-ASCT response assessment	Reference standard: clinical response based on International Uniform Criteria and bone marrow examination if any	Approximately 3 months after ASCT	No