Condition category
Cancer
Date applied
27/01/2016
Date assigned
27/01/2016
Last edited
26/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Contact information

Type

Public

Primary contact

Ms Wendy Underwood

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
+44 117 3422374
Wendy.Underwood@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 Trial

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

Other

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below 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 measures

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

04/09/2015

Overall trial end date

19/08/2017

Reason abandoned

Eligibility

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

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

04/09/2015

Recruitment end date

19/08/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

26/10/2016: Cancer Help UK lay summary link added.