Clinical trial NCT05234099: Sensitivity and Reproducibility of 18F-fluorodeoxyglucose Positron Emission Tomography for Assessment of Respiratory Muscle Activity
Official title: Evaluation of the Sensitivity and Reproducibility of 18F-fluorodeoxyglucose Positron Emission Tomography Coupled With Magnetic Resonance Imaging for the Assessment of Respiratory Muscle Activity and Relationships With Multiparametric Respiratory Muscle Ultrasound
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Muscle
Lead sponsor: Institut de Myologie, France
Sponsor class: OTHER
First posted: 2022-02-10
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 yo
* Non-smoker
* Signed informed consent
* Affiliate or beneficiary of a social security scheme

Non-Inclusion Criteria:

* Pregnant or breastfeeding women
* Respiratory, cardiovascular, metabolic, neuromuscular pathologies
* Claustrophobia
* Belonephobia
* Latex allergy
* Persons subject to a legal protection measure or unable to express their consent
* Contraindications to MRI (claustrophobia, metal implants)
* Inability to participate in the study
* Inability to comply with protocol requirements

Exclusion Criteria:

* Blood sugar\> 1.8 g / L (V1, V2, V3)
* Impossibility of inserting the esophageal and / or gastric tubes (V2, V3)

Primary outcomes:
measure: Correlation between multiparametric ultrasound and 18F-FDG PET-MRI during respiratory muscle activity measurement
timeFrame: Through study completion, on average 3 weeks
Secondary outcomes:
measure: Significant correlation between measurements of respiratory muscle activity assessed by pressure measurements and increased respiratory muscle work induced by the ventilation against inspiratory loading as assessed by 18F-FDG PET-MRI
timeFrame: Through study completion, on average 3 weeks
measure: Significant correlation between measures of respiratory muscle activity assessed by sEMG and respiratory muscle work induced by the ventilation against inspiratory loading as assessed by 18F-FDG PET-MRI
timeFrame: Through study completion, on average 3 weeks
Other outcomes:
Locations:
city: Orsay
country: France
facility: Service hospitalier Fréderic Joliot
city: Paris
country: France
facility: Association Institut de Myologie
Study officials:
affiliation: Institute of Myology
name: Damien Bachasson, PhD
role: PRINCIPAL_INVESTIGATOR
References: