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

NCT ID: NCT03885765

Last Updated: 2025-06-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 160 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-09-21
• Study Completion Date: 2025-04-18

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.

Conditions

Non-small Cell Lung Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Test group

The first 60 patients recruited.

Predictive data

Intervention Type: DIAGNOSTIC_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 resection

Intervention Type: PROCEDURE

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.

Validation group

The last 100 patients recruited.

Predictive data

Intervention Type: DIAGNOSTIC_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 resection

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sébastien Bommart, MD

Role: STUDY_DIRECTOR

University Hospitals of Montpellier, France

Locations

Chu Montpellier

Montpellier, , France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 34423004 (View on PubMed)

Other Identifiers

RECHMPL17_0370

Identifier Type: -

Identifier Source: org_study_id