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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Diagnostic Test: Predictive data
* Procedure: Lung resection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Test group<br>The first 60 patients recruited. | Diagnostic Test: Predictive data<br>* 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.<br>Procedure: Lung resection<br>* 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.<br>|
| Validation group<br>The last 100 patients recruited. | Diagnostic Test: Predictive data<br>* 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.<br>Procedure: Lung resection<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forced expiratory volume in 1 second (FEV1) from spirometry |  | 6 months | 
| Correlation between predicted and real values for post-surgical FEV1 |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimated post-operative FEV1 (litres) according to scintigraphy | Estimated post-operative FEV1 (litres) deduced from the regional FEV1 distribution according to lung scintigraphy | 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 | 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 | 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 | Baseline (day 0) | 
| Forced expiratory volume in 1 second (FEV1) from spirometry |  | Baseline (day 0) | 
| Forced vital capacity from spirometry |  | Baseline (day 0) | 
| Forced vital capacity from spirometry |  | 6 months | 
| FEV1/FVC from spirometry |  | Baseline (day 0) | 
| FEV1/FVC from spirometry |  | 6 months | 
| Total lung capacity from spirometry | lung volumes | Baseline (day 0) | 
| Total lung capacity from spirometry | lung volumes | 6 months | 
| Residual lung volume from spirometry | lung volumes | Baseline (day 0) | 
| Residual lung volume from spirometry | lung volumes | 6 months | 
| Functional residual lung capacity from spirometry | lung volumes | Baseline (day 0) | 
| Functional residual lung capacity from spirometry | lung volumes | 6 months | 
| Transfer factor of the lung for carbon monoxide (TLCO) from spirometry |  | Baseline (day 0) | 
| Transfer factor of the lung for carbon monoxide (TLCO) from spirometry |  | 6 months | 
| Maximum volume of oxygen utilized per unit time (VO2Max) |  | Baseline (day 0) | 
| Maximum volume of oxygen utilized per unit time (VO2Max) |  | 6 months | 
| EQ-5D-5L questionnaire | The 5 level EQ-5D version (EQ-5D-5L) is a standardized instrument for measuring generic health status. It results in a single index score describing a general health profile ranging from 0 to 1, as well as a visual analogue scale. | Baseline (day 0) | 
| EQ-5D-5L questionnaire | The 5 level EQ-5D version (EQ-5D-5L) is a standardized instrument for measuring generic health status. It results in a single index score describing a general health profile ranging from 0 to 1, as well as a visual analogue scale. | 6 months | 
| QLQ-C30 Version 3.0 questionnaire | The QLQ-C30 Version 3.0 (a quality of life questionnaire for lung cancer patients) results in three scale scores [(i) level of function, (ii) global health status, and (iii) symptomatology / problems] with higher scores (ranging from 0 to 100) representing a higher response level. | Baseline (day 0) | 
| QLQ-C30 Version 3.0 questionnaire | The QLQ-C30 Version 3.0 (a quality of life questionnaire for lung cancer patients) results in three scale scores [(i) level of function, (ii) global health status, and (iii) symptomatology / problems] with higher scores (ranging from 0 to 100) representing a higher response level. | 6 months | 
| QLQ-LC13 questionnaire | The QLQ-LC13 provide an additional lung-cancer-specific symptom scale ranging from 0 to 100 with higher scores indicating worse symptomatology. | Baseline (day 0) | 
| QLQ-LC13 questionnaire | The QLQ-LC13 provide an additional lung-cancer-specific symptom scale ranging from 0 to 100 with higher scores indicating worse symptomatology. | 6 months | 
| Number of participants with complications |  | 0 to 6 months |