NCT03779815

Brief Summary

\[18F\]Florbetaben PET/CT imaging will noninvasively assess amyloid deposition in systemic amyloidosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable multiple-myeloma

Timeline
Completed

Started Aug 2018

Shorter than P25 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

August 20, 2018

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 19, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
Last Updated

April 18, 2019

Status Verified

April 1, 2019

Enrollment Period

6 months

First QC Date

September 12, 2018

Last Update Submit

April 16, 2019

Conditions

Multiple Myeloma

Keywords

multiple myelomaamyloidosisFlorbetaben

Outcome Measures

Primary Outcomes (1)

  • sensitivity and specificity per patient analysis

    Sensitivity and specificity of \[18F\]Florbetaben PET/CT for the diagnosis of subjects with clinical, laboratory, radiological, or histopathological evidence of amyloidosis

    Up to 6 months after [18F]Florbetaben PET/CT scanning

Secondary Outcomes (3)

  • sensitivity and specificity per organ analysis

    Up to 6 months after [18F]Florbetaben PET/CT scanning

  • Correlation with severity

    Up to 6 months after [18F]Florbetaben PET/CT scanning

  • Adverse events

    Up to 28 days after [18F]Florbetaben PET/CT scanning

Study Arms (1)

[18F]Florbetaben PET/CT imaging

EXPERIMENTAL

* Maximally 18 subjects with multiple myeloma (up to 6 subjects in whom amyloidosis in suspected and up to 12 subjects in whom amyloidosis is not suspected) * Intravenous injection of \[18F\]Florbetaben and PET/CT scanning * Intervention: Drug (\[18F\]Florbetaben)

Drug: [18F]Florbetaben

Interventions

[18F]FlorbetabenDRUG

* Drug: \[18F\]Florbetaben * \[18F\]Florbetaben PET/CT Imaging for detecting amyloidosis in multiple myeloma * Other name: Neuraceq * Amount: 300 MBq ± 20% bolus, 10mL intravenously

Also known as: neuraceq
[18F]Florbetaben PET/CT imaging

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject is over 19 years old and male or female of any race/ethnicity
  • Subject has been diagnosed with multiple myeloma by a hemato-oncology specialist
  • Subject has undergone clinical, laboratory, or imaging work-up if amyloidosis is suspected
  • Subject has voluntarily agreed to participate in the study

You may not qualify if:

  • Subject or subject's legally acceptable representative does not provide written informed consent.
  • Subject has concurrent severe and/or uncontrolled and/or unstable medical disease (which could compromise participation in the study) in the judgment of the investigator.
  • Subject has received any investigational drugs or devices within four weeks prior to the study enrollment.
  • Subject has been previously included in this study.
  • Subject has any other condition or personal circumstances that, in the judgment of the investigator, might make collection of complete data difficult or impossible.
  • Subject is allergic to Florbetaben or any of ingredients of Florbetaben

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ulsan University Hospital

Ulsan, South Korea

Location

MeSH Terms

Conditions

Multiple MyelomaAmyloidosis

Interventions

4-(N-methylamino)-4'-(2-(2-(2-fluoroethoxy)ethoxy)ethoxy)stilbene

Condition Hierarchy (Ancestors)

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

Study Officials

  • Jae-Cheol Jo, PhD

    Ulsan University 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
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

September 12, 2018

First Posted

December 19, 2018

Study Start

August 20, 2018

Primary Completion

February 28, 2019

Study Completion

February 28, 2019

Last Updated

April 18, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)