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

NCT07053696 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2025-11-19

No results posted yet for this study

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

Interventions

DRUG

Technetium-99m Diethylenetriaminepentaacetic Acid

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.

DEVICE

EDDIS-IDDS (Enhanced Digital Dose Inhalation Delivery System)

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.

Sponsors & Collaborators

  • Ruslan Lytvin

    collaborator UNKNOWN

  • Andrey Petrov

    lead OTHER

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-17
Primary Completion
2025-11-17
Completion
2025-11-17

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07053696 on ClinicalTrials.gov