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NCT Number: NCT03885765

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

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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Montpellier

Montpellier, 34295, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: 6 months

  2. Correlation between predicted and real values for post-surgical FEV1

    Time frame: 6 months

Secondary outcomes

  1. Estimated post-operative FEV1 (litres) according to scintigraphy

    Time frame: Baseline (day 0)

    Estimated post-operative FEV1 (litres) deduced from the regional FEV1 distribution according to lung scintigraphy

  2. Estimated post-operative TLCO according to scintigraphy

    Time frame: Baseline (day 0)

    estimated post-operative Transfer factor of the lung for carbon monoxide (TLCO) deduced from the regional TLCO distribution

  3. Estimated post-operative FEV1 according segment counting (1)

    Time frame: Baseline (day 0)

    FEV1post-seg-1 = FEV1pre-op x (1 - 0.0526 x N), where N is the number of segments to be excised

  4. Estimated post-operative FEV1 according segment counting (2)

    Time frame: 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

  5. Forced expiratory volume in 1 second (FEV1) from spirometry

    Time frame: Baseline (day 0)

  6. Forced vital capacity from spirometry

    Time frame: Baseline (day 0)

  7. Forced vital capacity from spirometry

    Time frame: 6 months

  8. FEV1/FVC from spirometry

    Time frame: Baseline (day 0)

  9. FEV1/FVC from spirometry

    Time frame: 6 months

  10. Total lung capacity from spirometry

    Time frame: Baseline (day 0)

    lung volumes

  11. Total lung capacity from spirometry

    Time frame: 6 months

    lung volumes

  12. Residual lung volume from spirometry

    Time frame: Baseline (day 0)

    lung volumes

  13. Residual lung volume from spirometry

    Time frame: 6 months

    lung volumes

  14. Functional residual lung capacity from spirometry

    Time frame: Baseline (day 0)

    lung volumes

  15. Functional residual lung capacity from spirometry

    Time frame: 6 months

    lung volumes

  16. Transfer factor of the lung for carbon monoxide (TLCO) from spirometry

    Time frame: Baseline (day 0)

  17. Transfer factor of the lung for carbon monoxide (TLCO) from spirometry

    Time frame: 6 months

  18. Maximum volume of oxygen utilized per unit time (VO2Max)

    Time frame: Baseline (day 0)

  19. Maximum volume of oxygen utilized per unit time (VO2Max)

    Time frame: 6 months

  20. EQ-5D-5L questionnaire

    Time frame: Baseline (day 0)

    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.

  21. EQ-5D-5L questionnaire

    Time frame: 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.

  22. QLQ-C30 Version 3.0 questionnaire

    Time frame: Baseline (day 0)

    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.

  23. QLQ-C30 Version 3.0 questionnaire

    Time frame: 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.

  24. QLQ-LC13 questionnaire

    Time frame: Baseline (day 0)

    The QLQ-LC13 provide an additional lung-cancer-specific symptom scale ranging from 0 to 100 with higher scores indicating worse symptomatology.

  25. QLQ-LC13 questionnaire

    Time frame: 6 months

    The QLQ-LC13 provide an additional lung-cancer-specific symptom scale ranging from 0 to 100 with higher scores indicating worse symptomatology.

  26. Number of participants with complications

    Time frame: 0 to 6 months

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study 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

Acronym: CLIPPCAIR

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Mar 22, 2019
Registry last updated
Jun 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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