Clinical trial NCT03885765: Complication and Lung Function Impairment Prediction Using Perfusion and CT Air Trapping
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non-small Cell Lung Cancer
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2019-03-22
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The targeted study population corresponds to non-small cell lung cancer patients requiring pulmonary excision and who need to update their computed tomography scan data (CT scan) prior to surgery.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Forced expiratory volume in 1 second (FEV1) from spirometry
timeFrame: 6 months
measure: Correlation between predicted and real values for post-surgical FEV1
timeFrame: 6 months
Secondary outcomes:
measure: Estimated post-operative FEV1 (litres) according to scintigraphy
timeFrame: Baseline (day 0)
measure: Estimated post-operative TLCO according to scintigraphy
timeFrame: Baseline (day 0)
measure: Estimated post-operative FEV1 according segment counting (1)
timeFrame: Baseline (day 0)
measure: Estimated post-operative FEV1 according segment counting (2)
timeFrame: Baseline (day 0)
measure: Forced expiratory volume in 1 second (FEV1) from spirometry
timeFrame: Baseline (day 0)
measure: Forced vital capacity from spirometry
timeFrame: Baseline (day 0)
measure: Forced vital capacity from spirometry
timeFrame: 6 months
measure: FEV1/FVC from spirometry
timeFrame: Baseline (day 0)
measure: FEV1/FVC from spirometry
timeFrame: 6 months
measure: Total lung capacity from spirometry
timeFrame: Baseline (day 0)
measure: Total lung capacity from spirometry
timeFrame: 6 months
measure: Residual lung volume from spirometry
timeFrame: Baseline (day 0)
measure: Residual lung volume from spirometry
timeFrame: 6 months
measure: Functional residual lung capacity from spirometry
timeFrame: Baseline (day 0)
measure: Functional residual lung capacity from spirometry
timeFrame: 6 months
measure: Transfer factor of the lung for carbon monoxide (TLCO) from spirometry
timeFrame: Baseline (day 0)
measure: Transfer factor of the lung for carbon monoxide (TLCO) from spirometry
timeFrame: 6 months
measure: Maximum volume of oxygen utilized per unit time (VO2Max)
timeFrame: Baseline (day 0)
measure: Maximum volume of oxygen utilized per unit time (VO2Max)
timeFrame: 6 months
measure: EQ-5D-5L questionnaire
timeFrame: Baseline (day 0)
measure: EQ-5D-5L questionnaire
timeFrame: 6 months
measure: QLQ-C30 Version 3.0 questionnaire
timeFrame: Baseline (day 0)
measure: QLQ-C30 Version 3.0 questionnaire
timeFrame: 6 months
measure: QLQ-LC13 questionnaire
timeFrame: Baseline (day 0)
measure: QLQ-LC13 questionnaire
timeFrame: 6 months
measure: Number of participants with complications
timeFrame: 0 to 6 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Chu Montpellier
Study officials:
affiliation: University Hospitals of Montpellier, France
name: Sébastien Bommart, MD
role: STUDY_DIRECTOR
References:
citation: Suehs CM, Solovei L, Hireche K, Vachier I, Mariano Goulart D, Gamon L, Charriot J, Serre I, Molinari N, Bourdin A, Bommart S. Complication and lung function impairment prediction using perfusion and computed tomography air trapping (CLIPPCAIR): protocol for the development and validation of a novel multivariable model for the prediction of post-resection lung function. Ann Transl Med. 2021 Jul;9(13):1092. doi: 10.21037/atm-21-214.