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ThOracic Ultrasound in Idiopathic Pulmonary Fibrosis Evolution (TOUPIE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03944928
Recruitment Status : Recruiting
First Posted : May 10, 2019
Last Update Posted : July 8, 2019
Information provided by (Responsible Party):
University Hospital, Tours

Brief Summary:

Idiopathic pulmonary fibrosis (IPF) is one of the most common chronic idiopathic fibrotic interstitial lung disease (ILD). IPF is an evolving disease that requires regular follow-up through clinical examination, respiratory functional investigations and thoracic CT. Thoracic CT is necessary for the follow-up, usually performed yearly, and in case of deterioration of respiratory function. The disadvantages to its realization are the repeated irradiation, the cost, the accessibility, and sometimes the difficulties of realization related to the supine position.

Several signs of thoracic ultrasound have been described in ILD, including the number of B lines, the irregularity of the pleural line, and the thickening of the pleural line. Cross-sectional studies have correlated the intensity of these signs with the severity of fibrosis lesions on chest CT in patients with ILD, including IPF. However, no studies have prospectively described the evolution of ultrasound signs in the same IPF patient, or their correlation to clinical, functional and CT scan evolution.

The hypothesis is that thoracic ultrasound is a relevant tool to highlight the evolution of pulmonary lesions in IPF.

The main objective is to show with thoracic ultrasound an increase in one or more of the ultrasound signs: line B score, pleural line irregularity score, and pleural line thickness during the follow-up of patient with IPF.

The study will enroll patients with a validated diagnosis of IPF in a multidisciplinary staff. At each follow-up visit, patients will have a clinical examination, pulmonary functional test and thoracic ultrasound. The CT data collected will include the last thoracic CT performed in the 3 months before the inclusion and those performed during the patient's participation. The presence, location and severity of ultrasound signs, will be recorded for each patient during successive reassessments and correlation to clinical, functional and CT scan evolution will be made.

This study will add significant knowledge in the study of ultrasound signs evolution in patients with IPF. If there is a correlation with the clinical or CT scores, it will be possible to carry over the realization of the CTs to limit the irradiation of the patients. Conversely, early detection of worsening ultrasound signs may lead to faster therapeutic adjustments to limit the extent of irreversible fibrotic lesions.

Condition or disease Intervention/treatment
Idiopathic Pulmonary Fibrosis Other: Lung ultrasound

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: ThOracic Ultrasound in Idiopathic Pulmonary Fibrosis Evolution
Actual Study Start Date : June 11, 2019
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Intervention Details:
  • Other: Lung ultrasound

    For each usual consultation every 3 months, the patient will have clinical examination and pulmonary function tests (CPI score). Thoracic ultrasound will be made during the consultation (M0, M3, M6, M9 and M12). The presence, gravity and localisation of each ultrasound sign will be described. CT-scan data will be collected in the 3 months before the start of the study and during the study. To be enrolled in the study does not change to the usual follow-up.

    For the thoracic ultrasound, a convex probe will be used (1 to 5 MHz). Patient will be layed down in a right lateral prone position then left. Thoracic ultrasound will be timed, saved and anonymized. 14 intercostal spaces will be explored by experimented operator.

    The records will be seen a second time by same operator then a second operator. this will measured interoperator and intraoperator variability.

Primary Outcome Measures :
  1. Change of the B-line score from inclusion to 12 months [ Time Frame: Inclusion, 12 months ]
    number of line

  2. Change of pleural line irregularity from inclusion to 12 months [ Time Frame: Inclusion, 12 months ]

  3. Change of pleural line thickness from inclusion to 12 months [ Time Frame: Inclusion, 12 months ]
    in millimeters

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient with idiopathic pulmonary fibrosis

Inclusion Criteria:

  • more than 18 years-old
  • diagnosis of IPF validated in a multidisciplinary consultation meeting (RCP) according to French recommendations

Exclusion Criteria:

  • pregnant or lactating women
  • exacerbation of fibrosis on inclusion
  • right or left heart aggravation on inclusion
  • evolutive pulmonary infectious disease
  • other forms of diffuse interstitial lung disease
  • opposition to the data collection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03944928

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Contact: Thomas FLAMENT, MD 0247474747
Contact: Sylvie LEGUE

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CHR Orleans Not yet recruiting
Orléans, France, 45067
Contact: Hugues MOREL, MD    02 38 51 44 44   
Pulmonology Department, University Hospital, Tours Recruiting
Tours, France, 37044
Contact: Thomas FLAMENT, MD         
Principal Investigator: Thomas FLAMENT, MD         
Sponsors and Collaborators
University Hospital, Tours
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Responsible Party: University Hospital, Tours Identifier: NCT03944928    
Other Study ID Numbers: RIPH3-RNI19-TOUPIE
First Posted: May 10, 2019    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Tours:
Lung ultrasound
B lines
Pleural irregularity
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial