TARGET Trial

Not Applicable

Completed

• Conditions: Topic: Cancer; Subtopic: Lung Cancer; Disease: Lung (non-small cell); Cancer; Pleural malignancy

• Registration Number: ISRCTN14024829
• Lead Sponsor: orth Bristol NHS Trust

Brief Summary

2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/29616141 protocol 2024 Results article in https://doi.org/10.1183/13993003.01295-2023 (added 13/02/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-27
• Study Completion: 2019-09-30
• Last Update Posted: 12 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 78

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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