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

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.

Timeline

Start

2025-03-17

Primary completion

2025-11-17

Completion

2025-11-17

Outcome

Outcome not reported

Stopped (Enrollment): “Changing regulatory requirements requiring changes in study design. Participants were not enrolled”

Drugs

Indications

No indication recorded.