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

Non-small Cell Lung Cancer Clinical Trial

— CLIPPCAIR  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03885765
• Other study ID #: RECHMPL17_0370
• Status: Recruiting
• Start date: September 21, 2020
• Est. completion date: September 21, 2026

Study information

• Verified date: August 2023
• Source: University Hospital, Montpellier
• Contact: Sébastien Bommart, MD, PhD
• Phone: +33 (0)4.67.33.60.00
• Email: s-bommart[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: September 21, 2026
• Est. primary completion date: September 21, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-small Cell Lung Cancer

Intervention

Diagnostic Test:
• Predictive data
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.

Procedure:
• Lung resection
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.

Locations

Country	Name	City	State
France	Chu Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forced expiratory volume in 1 second (FEV1) from spirometry		6 months
Primary	Correlation between predicted and real values for post-surgical FEV1		6 months
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Forced expiratory volume in 1 second (FEV1) from spirometry		Baseline (day 0)
Secondary	Forced vital capacity from spirometry		Baseline (day 0)
Secondary	Forced vital capacity from spirometry		6 months
Secondary	FEV1/FVC from spirometry		Baseline (day 0)
Secondary	FEV1/FVC from spirometry		6 months
Secondary	Total lung capacity from spirometry	lung volumes	Baseline (day 0)
Secondary	Total lung capacity from spirometry	lung volumes	6 months
Secondary	Residual lung volume from spirometry	lung volumes	Baseline (day 0)
Secondary	Residual lung volume from spirometry	lung volumes	6 months
Secondary	Functional residual lung capacity from spirometry	lung volumes	Baseline (day 0)
Secondary	Functional residual lung capacity from spirometry	lung volumes	6 months
Secondary	Transfer factor of the lung for carbon monoxide (TLCO) from spirometry		Baseline (day 0)
Secondary	Transfer factor of the lung for carbon monoxide (TLCO) from spirometry		6 months
Secondary	Maximum volume of oxygen utilized per unit time (VO2Max)		Baseline (day 0)
Secondary	Maximum volume of oxygen utilized per unit time (VO2Max)		6 months
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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
Secondary	Number of participants with complications		0 to 6 months