A study of changing the order of scans in making a diagnosis of lung cancer.

Not Applicable

Completed

• Conditions: ung cancer; Lung cancer; Cancer - Lung - Non small cell; Cancer - Lung - Small cell

• Registration Number: ACTRN12618001789257
• Lead Sponsor: Royal Brisbane and Womens Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-01
• Study Completion: 2023-04-25
• Last Update Posted: 1 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 168

Inclusion Criteria

•Referrals to Thoracic Medicine OPD or Inpatient Consults
•Nodules 8-30mm diameter, solid or semi-solid
•Brock risk calculator risk of malignancy of >10%

Exclusion Criteria

•Unsuitable for bronchoscopy
•where nodules have morphology clearly suggestive of benign disease per BTS guidelines
peri-fissural or subpleural nodules less than 10 mm diameter.
oGround Glass opacity nodules with less than 5 mm solid component – see reference
•Pregnant or lactating women

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The study group will record decision making of first diagnostic test ( both before and after PET/CT) in the study data base. these are commonly made decisions, and rest on the position of the nodule ( more peripheral means more likely to have a CT FNA), whether associated with a bronchus - more likely to have a bronchoscopy with ebus guide sheath), classic features of a cancer in a fit patient with excellent lung function and a high risk prediction score for cancer ( might be considered direct for surgery), <br>so the outcome is CHANGE of biopsy strategy.<br>[Pre and Post the PET CT];Outcomes of biopsy sampling by pathology results - SENSITIVITY FOR MALIGNANCY BY TEST TYPE. [At entry, on basis of the final biopsy proven diagnosis];Clinical parameters regarding biopsy type- adverse events/ mortality[At the time of initial biopsy or procedure - up to first month post study inclusion. ]

Secondary Outcome Measures

Name	Time	Method
presence of air bronchograms on low dose CT chest: by radiologist report, comparing the initial referral CT chest, and this study CT. : the study group will record decision making of first diagnostic test ( both before and after low dose CT) in the study data base .[Pre and Post low dose CT chest];Diagnostic accuracy (sensitivity and specificity) of blood exosome test to identify cancerous modules as assessed by comparison to final pathologic diagnosis. [the result of the exosome test will be compared to final pathologic diagnosis once all lab pathology tests for tissue confirmation are available at the initial diagnostic workup (this may take up to 2-3 weeks for a final diagnosis to be made). ]