TARGET Trial

ISRCTN	ISRCTN14024829
DOI	https://doi.org/10.1186/ISRCTN14024829
Secondary identifying numbers	19364

Submission date: 27/01/2016
Registration date: 27/01/2016
Last edited: 02/08/2024

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-at-pet-ct-targeted-biopsy-to-diagnose-cancer-of-the-covering-of-the-lungs-target-0

Contact information

Ms Lucy Ellis
Public

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

Phone	+44 (0)117 3422374
Email	target-trial@bristol.ac.uk

Study information

Study design	Randomised; Interventional; Design type: Diagnosis
Primary study design	Interventional
Secondary study design	Randomised parallel trial
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
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
Study 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(s)	South West - Exeter Research Ethics Committee, 15/07/2015, 15/SW/0156
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
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 study start date	01/06/2015
Overall study end date	30/09/2019

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned Sample Size: 78; UK Sample Size: 78
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 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

England
Scotland
United Kingdom
Wales

Study participating centres

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

Queen Elizabeth University Hospital

1345 Govan Road
Govan
G51 4TF
United Kingdom

Gloucester Royal Hospital

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

Southmead Hospital

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

Royal Gwent Hospital

Cardiff Road
Newport
NP20 2UB
United Kingdom

Norfolk and Norwich University Hospital

Colney Lane
Norwich
NR4 7UY
United Kingdom

Churchill Hospital

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

Northern General Hospital

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

Royal Stoke University Hospital

Newcastle Road
Stoke-on-Trent
ST4 6QG
United Kingdom

Sponsor information

North Bristol NHS Trust
Hospital/treatment centre

Trust Headquarters
Beckspool Road
Frenchay
Bristol
B16 1JE
England
United Kingdom

"ROR"	https://ror.org/036x6gt55

Funders

Funder type

Government

National Institute for Health Research
Government organisation / National government

Alternative name(s): National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location: United Kingdom

Results and Publications

Intention to publish date	31/03/2020
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	19/02/2018		Yes	No
HRA research summary			28/06/2023	No	No
Results article		01/02/2024	13/02/2024	Yes	No
Plain English results			02/08/2024	No	Yes

Editorial Notes

02/08/2024: Added CRUK link to plain English results.
13/02/2024: Publication reference added.
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.