Complication and Lung Function Impairment Prediction Using Perfusion and CT Air Trapping (CLIPPCAIR)

University Hospital Center (CHU)

Status: Completed

Conditions: Non-small Cell Lung Cancer

Treatments: Procedure: Lung resection; Diagnostic Test: Predictive data

Study type: Observational

Funder types: Other

Identifiers

NCT03885765

RECHMPL17_0370

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 160 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

160 participants in 2 patient groups

Test group

Description:

The first 60 patients recruited.

Treatment:

Diagnostic Test: Predictive data

Procedure: Lung resection

Validation group

Description:

The last 100 patients recruited.

Treatment:

Diagnostic Test: Predictive data

Procedure: Lung resection