Contact information
Type
Public
Contact name
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/CTIS number
IRAS 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(s)
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
Study setting(s)
Hospital
Study 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
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
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(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 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 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
Study participating centre
Queen Elizabeth University Hospital
1345 Govan Road
Govan
G51 4TF
United Kingdom
Study participating centre
Gloucester Royal Hospital
Gloucestershire Hospitals NHS Foundation Trust
Great Western Road
Gloucester
GL1 3NN
United Kingdom
Study participating centre
Southmead Hospital
North Bristol NHS Trust
Southmead Road
Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom
Study participating centre
Royal Gwent Hospital
Cardiff Road
Newport
NP20 2UB
United Kingdom
Study participating centre
Norfolk and Norwich University Hospital
Colney Lane
Norwich
NR4 7UY
United Kingdom
Study participating centre
Churchill Hospital
Oxford University Hospitals NHS Foundation Trust
Old Road
Headington
Oxford
OX3 7LE
United Kingdom
Study participating centre
Northern General Hospital
Sheffield Teaching Hospitals NHS Foundation Trust
Herries Road
Sheffield
South Yorkshire
Sheffield
S5 7AU
United Kingdom
Study 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
England
United Kingdom
Sponsor type
Hospital/treatment centre
Website
ROR
Funders
Funder type
Government
Funder name
National Institute for Health Research
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
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
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 |