Business Decision
An Open-label Multicenter Phase 2 Dose-evaluation Study of Altropane (123I) Injection for Striatal Dopamine Transporter Visualization Using SPECT Brain Imaging
Sponsor study identifier
interventional
15
1 country
4
Study Start
April 24, 2023
Actual (reported)Primary Completion
June 8, 2024
Actual (reported)Study Completion
June 8, 2024
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 8, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 1, 2022
Actual (reported)December 5, 2022
Actual (reported)April 24, 2023
Actual (reported)June 8, 2024
Actual (reported)June 8, 2024
Actual (reported)July 15, 2025
Actual (reported)Striatal Visualization: Percentage of Participants With Correct Majority Classifications of 5-mCi Altropane Images as Determined by 5 Independent Blinded Readers
Assessment of the Altropane SPECT images was performed by 5 independent expert blinded readers to determine striatal uptake, reported as a forced choice of either normal (caudate and putamen fully visible on left and right, or with small insignificant defects) or abnormal (unilateral or bilateral reduced). Majority classification was determined from the majority interpretation of the 5 expert blinded readers (at least 3 of 5 readers).
Day 1, up to 30 minutes
Percentage of Participants With Confidence Ratings for 5-mCi Altropane Images as Evaluated by 5 Independent Blinded Readers (Reader Confidence in Striatal Visualization)
Day 1, up to 30 minutes
Percentage of Participants With Image Quality for 5-mCi Altropane Images as Evaluated by 5 Independent Blinded Readers (Reader Assessment of Image Quality)
Day 1, up to 30 minutes
Inter-Reader Agreement on Percentage of Participants With Normal Images
Day 1, up to 30 minutes
Percentage of Participants With One or More Treatment Emergent Adverse Events (TEAEs)
From administration of Altropane until 24 hours post dose
Percentage of Participants With Adverse Drug Reaction (ADR)
From administration of Altropane until 24 hours post dose
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Johns Hopkins University
Baltimore, Maryland, 21287, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
University of Mississippi Medical Center (UMMC)
Jackson, Mississippi, 39216, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
The study was terminated after completion of Part 1 by the Sponsor due to business decision. This decision was not due to safety concerns.
Paul Sherwin, MD, PhD
GE Healthcare
15 participants (actual enrollment reported by the registry).
First Submitted
November 1, 2022
First Posted
December 5, 2022
Study Start
April 24, 2023
Actual (reported)Primary Completion
Study to Evaluate the Efficacy and Safety of Staccato Apomorphine (AZ-009) in Patients With Parkinson's Disease Experiencing OFF Episodes
Contact the study team to confirm eligibility.
June 8, 2024
Actual (reported)Study Completion
June 8, 2024
Actual (reported)Last Updated
July 15, 2025
Results First Posted
July 15, 2025
Record last verified: 2025-06
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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