C11-Acetate PET/CT in Multiple Myeloma: Added Value to F1... | NCT01691300

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

NCT01691300

Sponsor

Chang Gung Memorial Hospital

Status

Completed

Last Update Posted

Nov 13, 2015Estimated

Enrollment

30Actual

Phase

Not Applicable

Conditions

Multiple Myeloma

Interventions

ACT PET/CT

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2011

Primary Completion Date

May 2015Actual

Completion Date

Nov 2015Actual

First Submitted Date

Sep 20, 2012

First Submission Date that Met QC Criteria

Sep 20, 2012

First Posted Date

Sep 24, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 11, 2015

Last Update Posted Date

Nov 13, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ACT PET/CT	Experimental	Dual-tracer ACT/FDG PET/CT and WB-DCE-MRI at baseline (pretreatment), post-induction and post-ASCT (if eligible)	Other: ACT PET/CT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ACT PET/CT	Other	Old tracer but new indication	ACT PET/CT

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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
Post-ASCT response assessment

Other Outcomes

Measure	Description	Time Frame
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

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Chieh Lin, MD, PhD	Department of Molecular Imaging Center and Nuclear Medicine, Chang Gung Memorial Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chang Gung Memorial Hostpial		Guishan	Taoyuan county	33305	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D009101	Multiple Myeloma

Ancestor Terms

ID	Term
D054219	Neoplasms, Plasma Cell
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D020141	Hemostatic Disorders

Browse Leaves

Not provided

Browse Branches

Not provided