Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05234099 |
| Other study ID # |
ResPET |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 5, 2022 |
| Est. completion date |
December 22, 2023 |
Study information
| Verified date |
April 2024 |
| Source |
Institut de Myologie, France |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The assessment of respiratory muscle function is critical within both clinical and research
settings. Tools for the assessment of respiratory muscle function are especially useful in
diagnosing, phenotyping, understanding pathophysiology, and assessing treatment responses in
patients with respiratory symptoms, including critically hill patients and patients with
respiratory and/or neuromuscular diseases. Respiratory muscle function is most commonly
assessed using flow (i.e. spirometry) and pressure measurements during spontaneous
ventilation, voluntary respiratory efforts, or artificially evoked responses using magnetic
or electrical stimulation. Some of these approaches may be limited within patients suffering
from neuromuscular diseases. The study hypothesis is the 18F-FDG PET technology, heavily used
for clinical oncology purposes (diagnostic, staging, response to treatment, prognosis), could
be an interesting alternative to invasive measurement of the respiratory muscle activity. In
addition, it may contribute to further validate metrics based on multiparametric ultrasound
imaging.
Description:
The assessment of respiratory muscle function is critical within both clinical and research
settings. Tools for the assessment of respiratory muscle function are especially useful in
diagnosing, phenotyping, understanding pathophysiology, and assessing treatment responses in
patients with respiratory symptoms, including critically hill patients and patients with
respiratory and/or neuromuscular diseases. Respiratory muscle function is most commonly
assessed using flow (i.e. spirometry) and pressure measurements during spontaneous
ventilation, voluntary respiratory efforts, or artificially evoked responses using magnetic
or electrical stimulation. Some of these approaches may be limited, for instance, when facial
muscle weakness occurs and/or when glottis function is compromised, for example in patients
with bulbar amyotrophic lateral sclerosis or myopathies. Consequently, widely used
respiratory measures can be poor predictors of respiratory muscle alterations and this may
contribute to affect clinical decisions such as the time when non-invasive ventilation should
be initiated within the disease continuum.
Positron emission tomography (PET) is a nuclear medicine procedure based on the measurement
of positron emission from radiolabeled tracer molecules. These radiotracers allow biologic
processes to be measured and whole-body images to be obtained which demonstrates sites of
radiotracer accumulation. Fluorodeoxyglucose (18F-FDG) is a radiolabeled glucose molecule and
is the most common radiotracer used in clinical practice. 18F-FDG PET is most frequently
coupled with computed tomography but may also be coupled with magnetic resonance imaging
(18F-FDG PET-MRI). 18F-FDG PET is heavily used for clinical oncology purposes (diagnostic,
staging, response to treatment, prognosis). 18F-FDG PET also finds applications in other
fields for detecting infections and inflammatory processes. 18F-FDG may also be used in
muscles that are major user of glucose. 18F-FDG PET offers the opportunity to assess the
patterns and work amount of multiple muscles simultaneously, providing a global view of the
muscles involved in the realization of a motor task, as previously demonstrated in shoulder
muscles.
Ultrasound imaging (US) is attracting a growing interest for the assessment of respiratory
muscle function, as it allows bedside and non-invasive assessments. Recently, new US
techniques such as shear wave elastography (SWE) have shown promises for the assessment of
respiratory muscle work. However, the ability of variables derived from respiratory muscle US
to reflect increased muscle work remains unclear. Hence, building evidences supporting
non-invasive US biomarkers for respiratory muscle function is necessary.
18F-FDG PET offers a unique opportunity to investigate patterns and work amount of the
respiratory muscles. In a resting state, 18F-FDG uptake in the respiratory muscle is known to
be small. However, and to the best of our knowledge, 18F-FDG uptake of the respiratory
muscles at rest in healthy subjects has never been specifically reported. It is unclear
whether 18F-FDG PET may be used to monitor changes in respiratory muscle activity within the
disease continuum or in response to an intervention such as the initiation of non-invasive
ventilation. The reproducibility of increase 18F-FDG uptake of the respiratory muscles
induced remains to be assessed and is a prerequisite to determine its sensitivity to change.
Moreover, the relationship between increase 18F-FDG uptake and respiratory muscle work as
assessed using other methods (e.g. flow and pressure measurements, surface electromyography
(sEMG)) and variables derived from multiparametric US remains to be determined. Since MRI
does not use ionizing radiations, and because of very higher soft-tissue contrast
capabilities, combining PET to MRI instead of CT is of better relevance for our PET muscular
analyses purpose.
