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[Phase 2 clinical study of 99mTc-ECD--a multicenter study].

Y Yonekura¹, Y Sasaki, A Kubo

¹Department of Brain Pathophysiology, Faculty of Medicine, Kyoto University.

Kaku Igaku. the Japanese Journal of Nuclear Medicine

|September 1, 1992

Summary

A new brain perfusion agent, 99mTc-ECD, demonstrated high safety and effectiveness in a phase 2 study for cerebrovascular diseases. This agent offers valuable diagnostic information for brain function impairment.

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Area of Science:

Nuclear Medicine
Radiopharmaceuticals
Neurology

Background:

Cerebrovascular diseases and impaired brain function require accurate diagnostic tools.
Evaluating novel brain perfusion agents is crucial for improving diagnostic capabilities.

Purpose of the Study:

To assess the effectiveness, safety, optimal dose, and imaging timing of the novel brain perfusion agent 99mTc-ECD.
To evaluate the clinical utility of 99mTc-ECD in patients with cerebrovascular diseases and brain function impairment.

Main Methods:

A multi-center phase 2 clinical study involving 166 patients across 10 institutions in Japan.
Administration of 99mTc-ECD followed by SPECT imaging at various time points post-injection.
Evaluation of safety, side effects, diagnostic information yield, and image quality.

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Main Results:

No safety issues or side effects were observed in any of the 166 cases.
Valuable diagnostic information was obtained in 98.3% (160/163) of evaluated cases.
Images acquired 60-90 minutes post-injection generally showed better quality; 400-800 MBq was deemed appropriate dosage.

Conclusions:

99mTc-ECD is a safe and highly effective radiopharmaceutical for brain perfusion imaging.
The agent provides valuable clinical diagnostic information for cerebrovascular diseases and brain function impairment.
Optimal imaging timing is between 60-90 minutes post-injection with a dose of 400-800 MBq.