Complication and Lung Function Impairment Prediction Using Perfusion and CT Air Trapping

Complication and Lung Function Impairment Prediction Using Perfusion and CT Air Trapping (CLIPPCAIR): Protocol for the Development and Validation of a Novel Algorithm for Post-resection Lung Function

The primary objective of the CLIPPCAIR study is to construct and validate a new algorithm for predicting post-operative forced expiratory volume in 1 second (FEV1) values for lung resection candidates; this new model will be based on data derived from a thoracic CT scan with injection of contrast media.

Secondarily, the predictions made using traditional scintigraphic data will be compared with those from the new algorithm in a subset of high-risk patients, and cumulative contrast media and irradiation doses associated with imaging will be presented. How other measures of pulmonary function (e.g. transfer factor of the lung for carbon monoxide (TLCO)) and the presence/absence of operative complications might be predicted will also be investigated. Additionally, the potential links between (i) pre-surgical imaging data, (ii) post-surgical changes in respiratory function, and (iii) changes in health related quality of life will also be explored.

Inclusion Criteria:

• Patient diagnosed with non-small cell lung cancer
• Indication for pulmonary excision surgery
• Patient requiring a more recent pre-surgical computed tomography scan (CT scan)
• The patient has been correctly informed about the study and has signed the consent form
• The patient is affiliated with or a beneficiary of the French single-payer social security programme (national health insurance)

Exclusion Criteria:

• Patient in an exclusion period determined by another protocol
• Participation in another study that may affect the results of the present study (anti-cancer treatment studies are allowed)
• Patient under legal or judicial protection
• Contraindication to surgery or iodine injection
• Pregnant or lactating women