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

Recruiting

• Conditions: Non-small Cell Lung Cancer
• Interventions: Diagnostic Test: Predictive data; Procedure: Lung resection

• Registration Number: NCT03885765
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

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

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 Timeline

• Study First Submitted: 2019-03-19
• Study First Submitted QC: 2019-03-19
• Study First Posted: 2019-03-22
• Study Start: 2020-09-21
• Status Verified: 2023-08
• Last Update Submitted: 2024-04-09
• Last Update Posted: 2024-04-10
• Primary Completion: 2025-09-21
• Study Completion: 2026-09-21

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Validation group	Predictive data	The last 100 patients recruited.
Test group	Lung resection	The first 60 patients recruited.
Validation group	Lung resection	The last 100 patients recruited.
Test group	Predictive data	The first 60 patients recruited.

Primary Outcome Measures

Name	Time	Method
Correlation between predicted and real values for post-surgical FEV1	6 months
Forced expiratory volume in 1 second (FEV1) from spirometry	6 months

Secondary Outcome Measures

Name	Time	Method
EQ-5D-5L questionnaire	6 months	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.
Number of participants with complications	0 to 6 months
Functional residual lung capacity from spirometry	6 months	lung volumes
Estimated post-operative FEV1 (litres) according to scintigraphy	Baseline (day 0)	Estimated post-operative FEV1 (litres) deduced from the regional FEV1 distribution according to lung scintigraphy
FEV1/FVC from spirometry	6 months
Total lung capacity from spirometry	6 months	lung volumes
Maximum volume of oxygen utilized per unit time (VO2Max)	6 months
Estimated post-operative TLCO according to scintigraphy	Baseline (day 0)	estimated post-operative Transfer factor of the lung for carbon monoxide (TLCO) deduced from the regional TLCO distribution
Transfer factor of the lung for carbon monoxide (TLCO) from spirometry	6 months
Estimated post-operative FEV1 according segment counting (1)	Baseline (day 0)	FEV1post-seg-1 = FEV1pre-op x (1 - 0.0526 x N), where N is the number of segments to be excised
Estimated post-operative FEV1 according segment counting (2)	Baseline (day 0)	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
Forced vital capacity from spirometry	6 months
Residual lung volume from spirometry	6 months	lung volumes
Forced expiratory volume in 1 second (FEV1) from spirometry	Baseline (day 0)
QLQ-LC13 questionnaire	6 months	The QLQ-LC13 provide an additional lung-cancer-specific symptom scale ranging from 0 to 100 with higher scores indicating worse symptomatology.
QLQ-C30 Version 3.0 questionnaire	6 months	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.

Trial Locations

Locations (1)

Chu Montpellier; 🇫🇷 Montpellier, France