NCT01691300

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable multiple-myeloma

Timeline
Completed

Started May 2011

Longer than P75 for not_applicable multiple-myeloma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 20, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 24, 2012

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

November 13, 2015

Status Verified

November 1, 2015

Enrollment Period

4 years

First QC Date

September 20, 2012

Last Update Submit

November 11, 2015

Conditions

Multiple Myeloma

Keywords

C11-acetate PET/CTMultiple myelomaPretreatment stagingResponse assessment

Outcome Measures

Primary Outcomes (1)

  • Pretreatment lesion detection

    Reference standards: bone marrow examination and whole-body dynamic contrast-enhanced MRI

    Within 2 weeks before initiation of therapy

Secondary Outcomes (2)

  • Post-induction response assessment

    Approximately 4 months after initiation of therapy depending on the regimen

  • Post-ASCT response assessment

    Approximately 3 months after ASCT

Other Outcomes (1)

  • Progression free survival

    With 2 years of follow-up time

Study Arms (1)

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

ACT PET/CTOTHER

Old tracer but new indication

ACT PET/CT

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hostpial

Guishan, Taoyuan County, 33305, Taiwan

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Chieh Lin, MD, PhD

    Department of Molecular Imaging Center and Nuclear Medicine, Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2012

First Posted

September 24, 2012

Study Start

May 1, 2011

Primary Completion

May 1, 2015

Study Completion

November 1, 2015

Last Updated

November 13, 2015

Record last verified: 2015-11

Locations

TW(1)