A New Pathway With BronchOscopic or Oesophageal Ultrasound for Lung Cancer Diagnosis and STaging (BOOST)

University College London Hospitals NHS Foundation Trust (UCLH)

Status and phase: Completed; Phase 3

Conditions: Bronchogenic Carcinoma

Treatments: Procedure: Endobronchial or Endoscopic Ultrasound; Procedure: Bronchoscopy, CT-guided biopsy, PET scan, Mediastinoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT00652769

07/0156

Details and patient eligibility

About

In the UK, staging of lung cancer is time consuming (taking on average more than 3 weeks), costly and inaccurate in up to 20% of cases. The investigators wish to determine whether using the newer techniques of endobronchial ultrasound (EBUS) and endoscopic ultrasound (EUS) improves lung cancer staging. The investigators' hypothesis is that EUS (endoscopic ultrasound) or EBUS (endobronchial ultrasound guided transbronchial needle aspirate) as a first test after CT scan in the diagnosis and staging of lung cancer will result in a reduction in the time from first outpatient appointment to treatment decision, a reduction in the total number of scans and investigative operations, fewer outpatient attendances and a reduction in healthcare costs.

Enrollment: 168 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Consecutive patients suspected of lung cancer on CT scan
• Written informed consent
• Able to tolerate bronchoscopy and thoracic surgery

Exclusion criteria

• Evidence of severe or uncontrolled systemic disease that makes it undesirable for the patient to participate in the trial
• Any disorder making reliable informed consent impossible
• Patients with extra-thoracic disease, supraclavicular lymphadenopathy or pleural effusion

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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168 participants in 2 patient groups

B

Active Comparator group

Description:

Control arm: Current practice for diagnosing and staging lung cancer. Most patients with intra-thoracic disease suspected of lung cancer will undergo bronchoscopy (or CT guided biopsy), PET scan and possibly mediastinoscopy.

Treatment:

Procedure: Bronchoscopy, CT-guided biopsy, PET scan, Mediastinoscopy

A

Experimental group

Description:

Active arm: A new pathway for the diagnosis and staging of lung cancer with endobronchial (EBUS) or endoscopic ultrasound (EUS) as a first test. If EBUS or EUS is negative the patient will have PET scan +/- mediastinoscopy.

Treatment:

Procedure: Endobronchial or Endoscopic Ultrasound