Condition category
Cancer
Date applied
27/01/2016
Date assigned
27/01/2016
Last edited
18/07/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Public

Primary contact

Ms Lucy Ellis

ORCID ID

Contact details

Clinical Trials and Evaluation Unit (CTEU)
Level 7
Queen's Building
Bristol Royal Infirmary
Marlborough Street
Bristol
BS2 8HW
United Kingdom
+44 (0)117 3422374
target-trial@bristol.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

19364

Study information

Scientific title

Randomised controlled trial to compare the diagnostic yield of Positron Emission Tomography Computerised Tomography (PET­ CT) targeted pleural biopsy versus CT­-guided pleural biopsy in suspected pleural malignancy

Acronym

TARGET

Study hypothesis

The aim of this study is to investigate if PET-CT targeted biopsies are more likely to give a diagnostic biopsy compared to a second CT guided biopsy in patients who are suspected of having pleural malignancy who have already had one non-diagnostic biopsy.

Ethics approval

South West - Exeter Research Ethics Committee, 15/07/2015, 15/SW/0156

Study design

Randomised; Interventional; Design type: Diagnosis

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Topic: Cancer; Subtopic: Lung Cancer; Disease: Lung (non-small cell)

Intervention

Participants are randomly allocated to one of two groups.

Intervention group: Participants will undergo a PET-CT scan prior to their CT guided biopsy. The PET-CT images and reports will be made available to the biopsy performing radiologists, ahead of the scheduled biopsy date.

Control group: Participants will undergo a CT guided biopsy alone.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measure

Diagnostic accuracy of the PET-CT scan in the detection of pleural malignancy is determined using biposy results.

Secondary outcome measures

1. Diagnostic delay
2. Number of hospital attendances
3. Number of invasive pleural procedures
4. Survival
5. Costs associated with health related resource use
6. Mesothelin levels

Overall trial start date

01/06/2015

Overall trial end date

30/09/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Current participant inclusion criteria as of 17/11/2017:
Participants may be eligible for the study if ALL the following apply:
1. Pleural thickening on CT suspicious for pleural malignancy
2. Have had any form of pleural biopsy in the last 12 months (either by thoracoscopy or under radiological guidance) which was non-diagnostic for cancer
3. Lung Cancer/mesothelioma MDT decision to perform further CT-guided biopsy to pursue a diagnosis

Previous participant inclusion criteria:
1. Aged 18 years or over
2. Pleural thickening on CT suspicious for malignancy
3. Have had any for of pleural biopsy in the last 6 months (either by thoracoscopy or under radiological guidance) which was non­diagnostic for cancer
4. Lung Cancer/Mesothelioma Multidisciplinary team (MDT) decision to perform further CT guided biopsy to pursue a diagnosis

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 78; UK Sample Size: 78

Participant exclusion criteria

Current exclusion criteria as of 17/11/2017:
Participants may not enter study if ANY of the following apply:
1. Unsuitable for a CT guided biopsy – inability to co-operate, lie still for the duration of the biopsy, uncorrectable coagulopathy, inability to tolerate a pneumothorax, severe underlying lung disease (patients with an FEV1 < 35% assessed using simple spirometry, see section 5.3.1)
2. Unable to give written informed consent
3. Pregnancy or lactation
4. Age <18 years
5. Pleural thickening not amenable to a radiologically guided biopsy
6. Talc pleurodesis in the previous 6 months

Previous exclusion criteria:
1. Unsuitable for CT guided biopsy ­ inability to co­operate, lie still for the duration of the biopsy, uncorrectable coagulopathy, inability to tolerate a pneumothorax, severe underlying lung disease (patients with an FEV1 <35% assessed using simple spirometry)
2. Unable to give written informed consent
3. Pregnancy or lactation
4. Aged under 18 years
5. Pleural thickening not amenable to Tru­cut biopsy
6. Prior Talc pleurodesis

Recruitment start date

10/11/2015

Recruitment end date

30/09/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Bristol Royal Infirmary (Coordinating centre)
Clinical Trials and Evaluation Unit (CTEU) Level 7, Queen's Building Bristol Royal Infirmary Marlborough Street
Bristol
BS2 8HW
United Kingdom

Trial participating centre

Queen Elizabeth University Hospital
1345 Govan Road
Govan
G51 4TF
United Kingdom

Trial participating centre

Gloucester Royal Hospital
Gloucestershire Hospitals NHS Foundation Trust Great Western Road
Gloucester
GL1 3NN
United Kingdom

Trial participating centre

Southmead Hospital
North Bristol NHS Trust Southmead Road Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom

Trial participating centre

Royal Gwent Hospital
Cardiff Road
Newport
NP20 2UB
United Kingdom

Trial participating centre

Norfolk and Norwich University Hospital
Colney Lane
Norwich
NR4 7UY
United Kingdom

Trial participating centre

Churchill Hospital
Oxford University Hospitals NHS Foundation Trust Old Road Headington
Oxford
OX3 7LE
United Kingdom

Trial participating centre

Northern General Hospital
Sheffield Teaching Hospitals NHS Foundation Trust Herries Road Sheffield South Yorkshire
Sheffield
S5 7AU
United Kingdom

Trial participating centre

Royal Stoke University Hospital
Newcastle Road
Stoke-on-Trent
ST4 6QG
United Kingdom

Sponsor information

Organisation

North Bristol NHS Trust

Sponsor details

Trust Headquarters
Beckspool Road
Frenchay
Bristol
B16 1JE
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

31/03/2020

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

2018 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/29616141

Publication citations

Additional files

Editorial Notes

18/07/2019: The following changes were made to the trial record: 1. The public contact was changed from "Wendy Underwood <Wendy.Underwood@bristol.ac.uk>" to "Lucy Ellis <target-trial@bristol.ac.uk>". 2. Eight trial participating centres were added. 10/08/2018: The following changes have been made to the trial record: 1. The overall trial end date has been changed from 30/09/2018 to 30/09/20192 2. The recruitment end date has been changed from 31/03/2018 to 30/09/2018 3. The intention to publish date has been changed from 19/08/2018 to 31/03/2020 06/04/2018: Publication reference added. 21/11/2017: The overall trial dates have been updated from 04/09/2015-19/08/2017 to 01/06/2015-30/09/2018. The recruitment dates have been updated from 04/09/2015-19/08/2017 to 10/11/2015-31/03/2018. 26/10/2016: Cancer Help UK lay summary link added.