Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04749433
Status:
TERMINATED
Last Update Posted:
2023-07-10
First Post:
2021-01-29
Brief Title:
Study of 11CCPPC to Assess the Safety and Tolerability in Patients With ALS
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
A Phase 1 Study to Assess the Safety and Tolerability of PET Imaging With 11CCPPC 5-cyano-N-4-4-11CMethylpiperazin-1-yl-2-Piperidin-1-ylPhenylFuran-2-carboxamide Radioligand in Patients With Amyotrophic Lateral Sclerosis
Status:
TERMINATED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
study stopped to enhance protocol and resume under different sponsor
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this study is to evaluate the safety of using the 5-cyano-N-4-4-11CMethylpiperazin-1-yl-2-Piperidin-1-ylPhenylFuran-2-carboxamide 11CCPPC radiotracer in positron emission tomography PET imaging of people with amyotrophic lateral sclerosis ALS The investigators are also interested to see whether use of this radiotracer reveals imaging differences between patients with ALS and healthy patients
Detailed Description:
This is a Phase 1 study of safety and tolerability of an investigational radiotracer drug called 5-cyano-N-4-4-11CMethylpiperazin-1-yl-2-Piperidin-1-ylPhenylFuran-2-carboxamide 11CCPPC A radiotracer is a substance that chemically marks certain structures in the body In this case 11CCPPC highlights structures expressing colony stimulating factor receptor CSF1R a receptor that is expressed on microglial cells A safety and tolerability study is looking to see if there are any unanticipated possibly harmful effects of the use of the radiotracer in humans However ultimately the investigators would like to know if this drug can be used to make better images of the brain for patients with amyotrophic lateral sclerosis ALS which could help doctors better understand the disease and help take care of patients with ALS This study will use a radiotracer to look for a chemical receptor which ALS patients have more of in the brain After receiving the radiotracer participants brains will be scanned with a positron emission tomography PET imaging machine
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None