Rational Approach to a Unilateral Pleural Effusion2 | NCT02834455

Studies
Rational Approach to a Unilateral Pleural Effusion2

NCT02834455

Sponsor

Simon Reuter

Status

Terminated

Last Update Posted

Dec 17, 2020Actual

Enrollment

200Actual

Phase

Not Applicable

Conditions

Lung Neoplasms

Interventions

Contrast-enhanced CT
PET-CT

Countries

Denmark

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

Dec 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Patient inclusion cannot be reached within timelimits

Expanded Access Info

Start Date

May 2015Actual

Primary Completion Date

Dec 15, 2020Actual

Completion Date

Dec 15, 2020Actual

First Submitted Date

Jun 17, 2015

First Submission Date that Met QC Criteria

Jul 12, 2016

First Posted Date

Jul 15, 2016Estimated

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

Dec 15, 2020

Last Update Posted Date

Dec 17, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Recurrent unilateral, non-infectious pleural exudate is suspicious for primary or secondary pleural malignancy. Both conditions are associated with 5-year survival of 10%. Work-up is difficult, as the pleural surface is large and <33% of pleural malignancies shed malignant cells to the pleural fluid. Even so, additional tissue biopsies are needed for establishing mutation status for targeted therapies.

Optimal imaging to guide tissue sampling is pivotal. PET-CT has higher sensitivity than conventional CT for detecting malignant lesions >10mm. However, no randomised trial has investigated differences in diagnostic accuracy, time-to-diagnosis, or economics. Falsely PET-positive lesions in e.g. colon however, lead to more derived tests than do CT alone.

Gold standard for pleural tissue sampling is the surgical (VATS) thoracoscopy, allowing direct visual guiding of tissue sampling from all pleural surfaces. Yet, globally the medical (pleuroscopy) thoracoscopy is more widely used: cheaper, outpatient procedure, but allows only sampling from the parietal pleura. To date, no randomised studies have compared medical and surgical thoracoscopy concerning diagnostic hit rates, adverse events, or economics.

The investigators will perform two randomized studies to investigate whether

PET/CT is comparable to CT alone
VATS is comparable to pleuroscopy concerning hit rate, total investigations performed, time-to-diagnosis.

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

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CE-CT scanning	Active Comparator	Contrast-enhanced CT scan of the thorax and abdomen.	Device: Contrast-enhanced CT
PET-CT scanning	Active Comparator	Positron-emission-CT scanning (low dose without contrast) of the thorax and abdomen.	Device: PET-CT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Contrast-enhanced CT	Device	50% of patients with unilateral pleural effusion will have performed a CE-CT	CE-CT scanning

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of diagnostic thoracoscopies (either MT or VATS)		2 years

Secondary Outcomes

Measure	Description	Time Frame
Number of derived investigations (i.e. gastroscopy, coloscopy)		2 years
Number of patients diagnosed with cancer (cancer = an unequivocal diagnosis of neoplastic disease; no cancer = clinically benign cause, and improved imaging at 6 month control)		2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with recurrent pleural effusion of unknown origin after a first pleural tap according to BTS guidelines.
Indication for thoracoscopy according to BTS guidelines.
Patients accept further investigation according to Danish and BTS guidelines.
Have received oral and written consent and agreed.
At the time of inclusion, above 18 years of age.

Exclusion Criteria:

Female patients: pregnancy or breastfeeding.
Lack of language comprehension.
Legally incompetent patients.
Life expectancy less than 3 month.
Contraindications to pleural tissue sampling.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 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
Uffe Boedtger, MD, PhD	ubt@regionsjaelland.dk	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Naestved Sygehus		Næstved		4700	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D008175	Lung Neoplasms

Ancestor Terms

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000072078	Positron Emission Tomography Computed Tomography

Ancestor Terms

ID	Term
D049268	Positron-Emission Tomography
D014055	Tomography, Emission-Computed
D007090	Image Interpretation, Computer-Assisted
D003952	Diagnostic Imaging

Browse Leaves

Not provided

Browse Branches

Not provided