NCT05636852

Altropane Dose for Imaging Patients With Suspected Parkinson's Disease

An Open-label Multicenter Phase 2 Dose-evaluation Study of Altropane (123I) Injection for Striatal Dopamine Transporter Visualization Using SPECT Brain Imaging

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: GE Healthcare · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Previous studies showed that a dose of 8 millicuries of Altropane was appropriate for imaging patients with suspected Parkinson's disease. This study determined if a lower dose (5 millicuries) would suffice.

Conditions

• Parkinson Disease
• Movement Disorders

Interventions

Type	Name	Description
DRUG	Altropane (123I) Injection	Each participant received a single intravenous (IV) administration of 5 millicuries (mCi) (185 megabecquerels \[MBq\]) of Altropane (123I) Injection on Day 1. Altropane SPECT images were acquired for 30 minutes starting 15 to 20 minutes after administration with Altropane. These images were visually interpreted by 5 expert independent blinded readers.

Timeline

• Start date: 2023-04-24
• Primary completion: 2024-06-08
• Completion: 2024-06-08
• First posted: 2022-12-05
• Last updated: 2025-07-15
• Results posted: 2025-07-15

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study