Pharmacokinetics, Safety, and Lung Deposition of 99mTc-DTPA Delivered Via the EDDIS System in Healthy Volunteers

NCT07053696 | Withdrawn Phase 1 DMC

• 1 other identifier: EDDIS-PK-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers

Keywords

Inhalation Device; Lung Deposition; Aerosol; Pulmonary Drug Delivery; Radiolabeled Aerosol; Technetium Tc 99m DTPA; Scintigraphy

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Within 24 hours post-inhalation

Secondary Outcomes (3)

• 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)

  Up to 4 hours post-dose (samples at 1, 2, and 4 hours)

• Cumulative urinary excretion of 99mTc-DTPA measured by gamma counter analysis

  up to 4 hours post-dose

• Digital accuracy of inspiratory parameter recording assessed by calibration comparison

  During inhalation procedure (real-time measurement)

Other Outcomes (3)

• Technical validation of the EDDIS inhalation delivery system performance assessment

  During and immediately after inhalation (0-30 minutes)

• Aerodynamic performance evaluation using particle size distribution analysis

  During inhalation procedure (0-10 minutes)

• Inspiratory effort modulation and control assessment using digital sensor analysis

  Real-time during inhalation procedure (0-10 minutes)

Study Arms (1)

Single Inhalation of 99mTc-DTPA via EDDIS System

EXPERIMENTAL

This arm includes all participants receiving a single inhaled dose of 99mTc-DTPA (radiolabeled aqueous solution in 0.9% NaCl, 2 ml total volume, 500-800 µCi), administered via the portable, breath-actuated EDDIS-IDDS (Enhanced Digital Dose Inhalation Delivery System). The procedure includes real-time digital recording of inspiratory parameters and post-inhalation planar scintigraphic imaging at 0, 15, and 30 minutes to assess pulmonary deposition. Pharmacokinetic samples (blood and urine) are collected for systemic exposure analysis. No control or comparator arm is included.

Drug: Technetium-99m Diethylenetriaminepentaacetic Acid; Device: EDDIS-IDDS (Enhanced Digital Dose Inhalation Delivery System)

Interventions

Technetium-99m Diethylenetriaminepentaacetic Acid DRUG

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.

Also known as: 99mTc-DTPA

Single Inhalation of 99mTc-DTPA via EDDIS System

EDDIS-IDDS (Enhanced Digital Dose Inhalation Delivery System) DEVICE

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.

Also known as: EDDIS digital inhaler, breath-actuated inhalation device

Single Inhalation of 99mTc-DTPA via EDDIS System

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 45 years
• Healthy adults with no clinically significant medical history
• Normal spirometry (FEV1 ≥ 80% predicted)
• Body Mass Index (BMI) between 18.5 and 29.9 kg/m²
• No prior exposure to radiopharmaceuticals in the past 12 months
• Able and willing to comply with study procedures and provide written informed consent

You may not qualify if:

• History of asthma, COPD, or other chronic respiratory conditions
• History of lung surgery, pulmonary embolism, or interstitial lung disease
• Any ongoing respiratory infection or fever ≥ 38.0°C at screening or study day
• Uncontrolled or progressive arterial hypertension
• Known cardiovascular disease (e.g., arrhythmia, ischemic heart disease, heart failure)
• Presence of blood in saliva, hemoptysis, or any known pulmonary bleeding
• Diagnosed pulmonary emphysema
• Known coagulation disorders or use of anticoagulant therapy
• History of hypersensitivity to perfluorocarbons, DTPA, or radiopharmaceutical agents
• Prior exposure to radiopharmaceuticals within the last 12 months
• Participation in another clinical trial within the last 60 days
• Pregnancy or breastfeeding
• Use of any investigational or prescription drug within 30 days prior to study drug administration
• Any condition which, in the opinion of the investigator, would pose a health risk or interfere with study interpretation

Sponsors & Collaborators

• Andrey Petrov: lead
• Ruslan Lytvin: collaborator

Study Sites (1)

Andrey Petrov Dr

Lausanne, Canton of Vaud, CH-1005, Switzerland

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: No masking will be applied. Participants, investigators, and outcomes assessors will be aware of the intervention, as this is a non-therapeutic, Phase 1 imaging and device validation study
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: All participants will receive a single inhaled dose of radiolabeled aerosol (99mTc-DTPA) via the EDDIS system under controlled conditions.

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: July 8, 2025
• Study Start: March 17, 2025
• Primary Completion: November 17, 2025
• Study Completion: November 17, 2025
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)