Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00427674
Status:
TERMINATED
Last Update Posted:
2010-10-06
First Post:
2007-01-25
Brief Title:
Assessment of the Biodistribution and Safety of 123-I MZINT in Healthy Subjects and Parkinson Disease Patients
Sponsor:
Institute for Neurodegenerative Disorders
Organization:
Institute for Neurodegenerative Disorders
Study Overview
Official Title:
Phase I Evaluation of 123-IMZINT as a Brain SPECT Tracer of Serotonin Transporters in Healthy Human Subjects
Status:
TERMINATED
Status Verified Date:
2010-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Scan results to date did not show reason to continue with study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The overall plan of this project is to evaluate 123I mZINT as a tool to assess SERT density in humans This protocol will be completed in three parts In Part A serial dynamic SPECT will be acquired after injection of 123I mZINT in healthy controls to assess regional brain uptake in human subjects If Part A demonstrates robust brain region specific uptake then Part B - additional studies in healthy subjects to assess biodistribution and Part C - studies in PD subjects to compare regional uptake to healthy controls will be completed
Detailed Description:
All study procedures will be conducted at the Institute for Neurodegenerative Disorders IND and Molecular NeuroImaging MNI in New Haven CT Approximately 10 6 -Part A and 4 - Part B healthy subjects and 10 PD subjects will be recruited from the IND databases patient spouses and the community to participate in this protocol The study doctor will discuss the study procedures and evaluate the subject for eligibility All subjects will undergo written informed consent and a screening evaluation including baseline clinical laboratory testing and a baseline physical and neurological evaluation
Following bolus intravenous injection of 5 mCi of 123-I mZINT over 15 seconds serial dynamic SPECT brain acquisitions will be obtained to evaluate the regional brain uptake and washout of activity Venous blood measures will be obtained with each acquisition and characterization of 123-I mZINT and metabolites will be assessed Safety assessments will include vital signs serum chemistries CBC urinalysis and EKG
Vital signs will be assessed at pre-injection baseline and 15 30 60 and 90 minutes following the infusion of 123-I mZINT An EKG will be obtained at baseline and at 20 and 40 min post 123-I mZINT injection Adverse events will be assessed when vital signs are obtained Clinical laboratory tests performed at baseline and after each injection including the following serum chemistry battery complete blood count with differential and urinalysis
Following bolus intravenous injection of 5 mCi of 123-I mZINT over 15 seconds serial dynamic SPECT brain acquisitions will be obtained to evaluate the regional brain uptake and washout of activity Venous blood measures will be obtained with each acquisition and characterization of 123-I mZINT and metabolites will be assessed Safety assessments will include vital signs serum chemistries CBC urinalysis and EKG
Vital signs will be assessed at pre-injection baseline and 15 30 60 and 90 minutes following the infusion of 123-I mZINT An EKG will be obtained at baseline and at 20 and 40 min post 123-I mZINT injection Adverse events will be assessed when vital signs are obtained Clinical laboratory tests performed at baseline and after each injection including the following serum chemistry battery complete blood count with differential and urinalysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None