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Clinical Trial Summary

Up to 20 subjects will receive an injection with [11C]-UCB-J followed by a PET scan on Days 1 and 28


Clinical Trial Description

After assessing eligibility during a 4-week screening period, approximately 20 subjects will participate in the PET acquisition phase of the study. Drop-outs or unevaluable subjects will be replaced for a target sample size of 20 completed and evaluable subjects.

During the screening period, a 3D T1-weighted MRI must be acquired and reviewed for exclusion criteria and acquisition quality.

On the day of radioligand administration (Day 1), subjects will come to the study center for an ambulatory visit (Visit 1). After reā€confirming eligibility, all subjects will receive an injection with [11C]-UCB-J followed by a PET scan.

Using an arterial line and manual sampling, blood samples will be collected up to 90 minutes after radioligand injection in order to quantify radioactivity concentration in whole blood and plasma as well as parent fraction over time.

Subjects will return to the clinic for one more ambulatory visit on Day 28 ± 3 (Visit 2). The same procedures will be performed as on Day 1.

PET scanning duration will be initially set to 90 minutes. After a minimum of 4 subjects have completed baseline and Day 28 scans, 90 minute and 60 minute scan data will be analyzed. Based on this analysis, and at the discretion of the investigator, it will be decided whether the remaining subjects will require 60 or 90 minute scans.

Adverse events will be recorded throughout the study. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03577262
Study type Interventional
Source Rodin Therapeutics
Contact Floor Morrien
Phone 31 50 304 8000
Email floor.morrien@qps.com
Status Recruiting
Phase Early Phase 1
Start date July 23, 2018
Completion date January 20, 2019

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