NCT03272997

Brief Summary

The investigators aim is to asses the diagnostic power of 18F-FDG PET-CT in discriminating malignant from nonmalignant causes in patients with a recurrent unilateral pleural effusion of unknown origin.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
112

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2017

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

First Submitted

Initial submission to the registry

August 30, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 6, 2017

Completed
25 days until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2018

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2019

Completed
Last Updated

December 17, 2020

Status Verified

December 1, 2020

Enrollment Period

4 months

First QC Date

August 30, 2017

Last Update Submit

December 15, 2020

Conditions

Pleural Effusion, Malignant

Keywords

Positron emission thomographyComputed tomographySensitivitySpecificity

Outcome Measures

Primary Outcomes (1)

  • Sensitivity PET-CT

    TP / (TP + FN)

    1 year

Secondary Outcomes (14)

  • CT-Specificity

    1 year

  • PET-CT-Specificity

    1 year

  • CT-Sensitivity

    1 year

  • Comparison of the diagnostic power

    1 year

  • CT-Likelihood ratio+

    1 Year

  • +9 more secondary outcomes

Eligibility Criteria

Age16 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients with a unilateral pleural effusion of unknown origin examined with the above

You may qualify if:

  • Thoracocentesis
  • Chest X-ray
  • CT scanning
  • PET-CT scanning

You may not qualify if:

  • Missing data
  • Lung cancer
  • Thoracic malignancies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Naestved Hospital

Næstved, 4700, Denmark

Location

MeSH Terms

Conditions

Pleural Effusion, MalignantHypersensitivity

Condition Hierarchy (Ancestors)

Pleural NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsPleural EffusionPleural DiseasesRespiratory Tract DiseasesImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Principal investigator

Study Record Dates

First Submitted

August 30, 2017

First Posted

September 6, 2017

Study Start

October 1, 2017

Primary Completion

January 31, 2018

Study Completion

January 30, 2019

Last Updated

December 17, 2020

Record last verified: 2020-12

Locations

DK(1)