Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03944928 |
| Other study ID # |
RIPH3-RNI19-TOUPIE |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 11, 2019 |
| Est. completion date |
September 9, 2021 |
Study information
| Verified date |
October 2021 |
| Source |
University Hospital, Tours |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
- Clinical and scientic background Interstitial lung disease (ILD) is defined by an
inflammatory, often fibrotic, and diffuse process, predominant in the pulmonary interstitium.
Idiopathic pulmonary fibrosis (IPF) is one of the most common chronic idiopathic fibrotic
interstitial lung disease. IPF is an scalable disease that requires regular follow-up through
clinical examination and respiratory functional investigations. A thoracic CT scan is usually
performed annually in the absence of exacerbation. CT scan is essential for initial diagnosis
and follow-up, especially in case of deterioration of respiratory function. The main
disadvantages to its realization are the repeated irradiation, the cost, the accessibility,
and sometimes the difficulties of realization related to the supine position and the
maintenance of a prolonged apnea in patients with severe dyspnea.
For several years, the semiology of interstitial lung diseases has been enriched by the
description of several signs of thoracic ultrasound, including the number of B lines, the
irregularity of the pleural line, and the thickening of the pleural line. Several
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 evolution.
The hypothesis is that thoracic ultrasound is a relevant tool to highlight the evolution of
pulmonary lesions in IPF.
- Objective of the study: 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
secondary objectives are to evaluate the reproducibility of the measurements of the
pulmonary ultrasound signs, to evaluate the association between the severity of each
pulmonary ultrasound sign and the severity of the clinical, functional and CT scores and
to evaluate the association between the measurement of each ultrasound sign made during
a standard protocol exploring 14 intercostal spaces and a simplified protocol exploring
6 intercostal spaces.
- Design: This is a prospective, multicenter, non-interventional, prospective study
evaluating patients followed for IPF at the University Hospital of Tours and the
Hospital of Orléans, France.
Number of participants: 30
- Interventions and analysis: The study will enroll patients with a validated diagnosis of
IPF in a multidisciplinary staff. For each patient included, study duration will be 12
months. 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.
Thoracic ultrasonography will be performed on D0, M3, M6, M9 and M12. It will occur during
the follow-up consultation carried out as part of usual care. Thus, inclusion in the study
does not change the usual rhythm of consultations or complementary examinations (pulmonary
functional tests and thoracic CT scan) in the care of the patient.
A convex probe (1 to 5 MHz) will be used. The patient will be placed in right lateral
decubitus then left. Thoracic ultrasonography will be timed, recorded and anonymized. It will
be practiced by experienced operators and according to a validated protocol allowing the
exploration of 14 intercostal spaces. The recording loops will be read over later by the
operator himself and then by a second operator to evaluate the intra- and inter-operator
variability respectively.
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.
