[Clinical usefulness of 99mTc-ECD--a multicenter phase 3 study]

Area of Science:

• Nuclear Medicine
• Radiopharmaceuticals
• Cerebrovascular Imaging

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 safety, effectiveness, and clinical usefulness of 99mTc-L,L-ethyl cysteinate dimer (99mTc-ECD) as a brain perfusion agent.
• To compare 99mTc-ECD with 99mTc-hexamethylpropyleneamine oxime (99mTc-HM-PAO) in a multi-center clinical trial.

Main Methods:

• Phase 3 multi-center clinical study involving 521 patients with cerebrovascular diseases or impaired brain function.
• Evaluation of diagnostic information obtained from 99mTc-ECD brain perfusion imaging.
• Comparison of lesion detection characteristics (size, contrast) with 99mTc-HM-PAO.

Main Results:

• Valuable diagnostic information was obtained in 95.3% of evaluated cases (486/510).
• 99mTc-ECD was judged as "extremely useful" or "useful" in 87.1% of cases (444/510).
• Abnormal regions detected by 99mTc-ECD showed a tendency for larger size and higher contrast compared to 99mTc-HM-PAO.

Conclusions:

• 99mTc-ECD is a safe and useful radiopharmaceutical for brain perfusion imaging.
• The agent demonstrates significant utility in the diagnosis of cerebrovascular diseases and impairment of brain function.
• 99mTc-ECD offers potential advantages in lesion visualization over 99mTc-HM-PAO.