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

NCT03885765 | Completed

• 1 other identifier: RECHMPL17_0370
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Forced expiratory volume in 1 second (FEV1) from spirometry

  6 months

• Correlation between predicted and real values for post-surgical FEV1

  6 months

Secondary Outcomes (26)

• Estimated post-operative FEV1 (litres) according to scintigraphy

  Baseline (day 0)

• Estimated post-operative TLCO according to scintigraphy

  Baseline (day 0)

• Estimated post-operative FEV1 according segment counting (1)

  Baseline (day 0)

• Estimated post-operative FEV1 according segment counting (2)

  Baseline (day 0)

• Forced expiratory volume in 1 second (FEV1) from spirometry

  Baseline (day 0)

Study Arms (2)

Test group

The first 60 patients recruited.

Diagnostic Test: Predictive data; Procedure: Lung resection

Validation group

The last 100 patients recruited.

Diagnostic Test: Predictive data; Procedure: Lung resection

Interventions

Predictive data 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.

Test group; Validation group

Lung resection 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.

Test group; Validation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Chu Montpellier

Montpellier, 34295, France

Location

Related 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.

  PMID: 34423004 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

40 resected lung tissues for the routine pathological analysis may be retained for ancillary studies if the investigator : * deems that sample recovery is feasible * judges the distance between the cancerous lesion and the region of interest, sufficiently large/distinct * obtained the patient's consent for the use of his remaining excised tissue specifically for this ancillary study These lung tissues can't be retained if : * unavailability of tissue sample due to routine analysis requirements * patient has atelectasis * patient has pulmonary infection * patient has a pulmonary lesion linked to the surgical intervention

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Sébastien Bommart, MD

  University Hospitals of Montpellier, France

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2019
• First Posted: March 22, 2019
• Study Start: September 21, 2020
• Primary Completion: April 18, 2025
• Study Completion: April 18, 2025
• Last Updated: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Datasets can be requested after the publication process has been completed.
• Access Criteria: The conditions under which members of the public will be granted access to datasets are: * The data will be used/examined in a not-for-profit manner; * The data will not be used in an attempt to identify a participant or group of participants; * The user does not work for a private insurance company; * The data will not be used in support of any kind of private insurance policy or health penalties; * The data will be used/examined for the advancement of science/teaching while respecting participant/patient privacy and rights; * The user will state why they wish to access the data. * The appropriate CNIL approval has been obtained by the user.

Locations

FR (1)