NCT01466426

Brief Summary

This pilot study aims at validating 18F-flourodeoxyglucose positron emission tomography/computed tomography (FDG-PET/CT) in the detection and characterization of venous thromboembolism (VTE) in the entire human body, especially deep venous thrombosis (DVT) and pulmonary embolism (PE). On completion of this study the investigators will hopefully be able to demonstrate the importance of functional/molecular imaging technique in managing patients with this common and potentially fatal disorder.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2011

Typical duration for all trials

Geographic Reach
1 country

3 active sites

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

November 1, 2011

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 3, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 8, 2011

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

October 28, 2014

Status Verified

October 1, 2014

Enrollment Period

2.1 years

First QC Date

November 3, 2011

Last Update Submit

October 26, 2014

Conditions

Venous Thromboembolic Disease

Keywords

Venous thromboembolic diseaseDeep veinous thrombosisPulmonary embolism

Outcome Measures

Primary Outcomes (1)

  • Proof-of-concept

    Simple assessment of scans - positive or negative in the relevant patient categories

    During diagnostic workup

Study Arms (4)

DVT confirmed

DVT ruled out

PE confirmed

PE ruled out

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population comprises the following patient groups: 10 patients with a positive diagnosis of DVT, 10 patients where clinically suspected DVT was ruled out, 10 patients with a positive diagnosis of PE, and 10 patients where clinically suspected PE was ruled out.

You may qualify if:

  • Positive or negative diagnosis of VTE (DVT/PE)
  • Age ≥ 50 years
  • Informed consent obtained
  • Symptoms \< 1 week

You may not qualify if:

  • Pregnant or lactating women
  • Foreign language patients with a need for an interpreter
  • Previous DVT or PE
  • Known malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Dept. of Acute Medicine, Odense University Hospital

Odense, dk-5000, Denmark

Location

Dept. of Nuclear Medicine, Odense University Hospital

Odense, dk-5000, Denmark

Location

Dept. of Respiratory Medicine, Odense University Hospital,

Odense, dk-5000, Denmark

Location

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Soeren Hess, MD

    Odense University Hospital

    STUDY CHAIR

  • Poul Henning Madsen, MD

    Odense University Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 3, 2011

First Posted

November 8, 2011

Study Start

November 1, 2011

Primary Completion

December 1, 2013

Study Completion

June 1, 2014

Last Updated

October 28, 2014

Record last verified: 2014-10

Locations

DK(3)