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

University Hospital, Montpellier160 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

160

Conditions

Non-small Cell Lung Cancer

Interventions

Predictive dataDIAGNOSTIC_TEST

The novel predictive data in this study includes 5 predefined variables derived from thoracic CT scans: (i) Expiratory to inspiratory ratio of mean lung density (MLDe/i), total; (ii) MLDe/i of the section to be excised / MLDe/i total; (iii) Percentage of emphysema according to voxel thresholding at -950 HU (PVOX-950), total; (iv) PVOX-950 for the section to be excised; (v) Iodine concentration \[I\] of the section to be excised / \[I\] total.

Lung resectionPROCEDURE

Surgical resection will be characterised by type (pneumonectomy, bi-lobectomy, lobectomy, or lobectomy with anastomosis resection), whether or not lymph node dissection was performed, and whether or not the resection was atypical.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Chu Montpellier

Montpellier, France

Outcomes

Primary Outcomes

Forced expiratory volume in 1 second (FEV1) from spirometry

Time frame: 6 months

Correlation between predicted and real values for post-surgical FEV1

Time frame: 6 months

Secondary Outcomes

Estimated post-operative FEV1 (litres) according to scintigraphy

Estimated post-operative FEV1 (litres) deduced from the regional FEV1 distribution according to lung scintigraphy

Time frame: Baseline (day 0)

Estimated post-operative TLCO according to scintigraphy

estimated post-operative Transfer factor of the lung for carbon monoxide (TLCO) deduced from the regional TLCO distribution

Time frame: Baseline (day 0)

Estimated post-operative FEV1 according segment counting (1)

FEV1post-seg-1 = FEV1pre-op x (1 - 0.0526 x N), where N is the number of segments to be excised

Time frame: Baseline (day 0)

Estimated post-operative FEV1 according segment counting (2)

FEV1post-seg-2 = FEV1pre-op x \[(19 - a - b)/(19 - a)\], where a is the number of non-obstructed segments to be excised and b is the number of obstructed segments to be excised

Time frame: Baseline (day 0)

Forced expiratory volume in 1 second (FEV1) from spirometry

Time frame: Baseline (day 0)

Forced vital capacity from spirometry

Time frame: Baseline (day 0)

Data from ClinicalTrials.gov

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