Device: EDDIS-IDDS (Enhanced Digital Dose Inhalation Delivery System) - a portable, breath-actuated, digitally monitored system for precision delivery of inhaled agents with automated recording of inspiratory volume, flow, duration, and breath-hold parameters. Drug: 99mTc-DTPA (technetium-99m diethylenetriaminepentaacetic acid) - administered in aqueous solution (0.9% NaCl), radiolabeled for gamma scintigraphic imaging. Total dose: 500-800 µCi in 2 ml solution. Administration: Single-dose inhalation under supervision in a clinical setting.
This Phase 1, single-center, open-label clinical study is designed to evaluate the safety, pharmacokinetics, inhalation dynamics, segmental lung deposition, and digital monitoring capabilities of the breath-actuated EDDIS-IDDS (Enhanced Digital Dose Inhalation Delivery System) when used to deliver a radiolabeled aqueous formulation containing 99mTc-DTPA and a microdose of perfluorocarbon emulsion. The investigational aerosol is administered via a digitally controlled inhalation system that automatically triggers delivery based on the patient's inspiratory effort. The system continuously records real-time parameters including tidal volume, inspiratory flow rate, inhalation duration, and breath-hold time. These data are securely transmitted and stored for analysis, enabling high-resolution correlation between inhalation patterns and lung deposition outcomes. The radiolabel (99mTc-DTPA) is confined to the aqueous phase of the aerosol. The perfluorocarbon emulsion is included to simulate the aerodynamic behavior of complex liquid formulations and to evaluate their interaction with the lung architecture under controlled inhalation conditions. Radiolabeling is not applied to the perfluorocarbon phase, ensuring imaging specificity and avoiding nonspecific signal interference. Imaging will be performed using planar gamma scintigraphy at 0, 15, and 30 minutes post-inhalation. Anterior and posterior projections will be acquired to allow quantitative segmental lung analysis. Measurements will include total deposition, central vs. peripheral distribution, and temporal sedimentation characteristics. In parallel, blood samples will be collected at 1, 2, and 4 hours post-dose to determine systemic pharmacokinetics of the radiolabeled tracer. Urine samples collected at 4 hours will be used to calculate cumulative renal excretion. Adverse events, vital signs, and laboratory parameters will be monitored for 24 hours post-inhalation to assess tolerability and safety. This study aims to establish a validated digital platform for inhaled delivery research and serve as a reference model for future studies involving targeted pulmonary therapeutics and diagnostic aerosols.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Technetium-99m Diethylenetriaminepentaacetic Acid A single inhaled dose of 99mTc-DTPA in 0.9% sodium chloride solution, total volume 2 ml, with radioactivity of 500-800 µCi. The solution is radiolabeled only in the aqueous phase to allow gamma scintigraphic imaging of pulmonary deposition. Delivered via breath-actuated EDDIS system. The formulation includes a non-labeled microdose of perfluorocarbon emulsion to simulate clinical aerodynamic behavior.
Portable, maintenance-free breath-actuated inhalation delivery system with integrated digital sensors. Records real-time data including inspiratory volume, flow rate, duration, and breath-hold time. Provides controlled aerosol delivery and secure transmission of inhalation parameters to the clinical monitoring platform.
Andrey Petrov Dr
Lausanne, Canton of Vaud, Switzerland
Segmental lung deposition of 99mTc-DTPA measured by planar gamma scintigraphy
Quantitative analysis of 99mTc-DTPA distribution in lung segments using planar gamma scintigraphy imaging system with anterior/posterior views at 0, 15, and 30 minutes post-dose. Results expressed as percentage of total deposited dose per lung segment.
Time frame: Within 30 minutes post-inhalation
Incidence of treatment-emergent adverse events (TEAEs) assessed by clinical evaluation
Number and severity of adverse events recorded after a single inhalation of 99mTc-DTPA via the EDDIS system, assessed through standardized clinical observation checklist, vital signs monitoring (blood pressure, heart rate, respiratory rate, temperature), and structured subject symptom reports using Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Time frame: Within 24 hours post-inhalation
Radioactivity concentration in venous blood samples measured using gamma counter to determine systemic absorption of inhaled 99mTc-DTPA over time. Results expressed as counts per minute per milliliter (cpm/mL)
Radioactivity in venous blood samples to determine systemic absorption of inhaled 99mTc-DTPA over time
Time frame: Up to 4 hours post-dose (samples at 1, 2, and 4 hours)
Cumulative urinary excretion of 99mTc-DTPA measured by gamma counter analysis
Total radioactivity in collected urine samples measured using gamma counter to estimate renal elimination of 99mTc-DTPA. Results expressed as percentage of administered dose excreted
Time frame: up to 4 hours post-dose
Digital accuracy of inspiratory parameter recording assessed by calibration comparison
Comparison of EDDIS-recorded inspiratory volume (mL), flow rate (L/min), inhalation time (seconds), and breath-hold duration (seconds) with reference calibration measurements using validated spirometry equipment. Accuracy expressed as percentage deviation from reference values.
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Time frame: During inhalation procedure (real-time measurement)