Ignite Creation Date:
2024-05-06 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 2:30 PM
Study NCT ID:
NCT05335811
Status:
RECRUITING
Last Update Posted:
2024-04-18
First Post:
2022-02-18
Brief Title:
First-in-Human Assessment of Safety Biodistribution and Pharmacokinetics of 18F-Fluoro-1-Naphthol 18F-4FN for PET Imaging
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
First-in-Human Assessment of Safety Biodistribution and Pharmacokinetics of 18F-Fluoro-1-Naphthol 18F-4FN for PET Imaging
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
18F-4FN represents a novel PET agent for imaging inflammation Acute inflammatory signaling through the TLR axis recruits neutrophils and macrophages to inflammatory sites Both cells activate the production of high energy reactive oxygen speciesreactive nitrogen species RONS setting off a cascade that can be leveraged to detect the presence of these inflammatory cells by molecular imaging 18F-4FN is efficiently oxidized by high energy RONS leading to retention and accumulation in human neutrophil-like cells in vitro and at the sites of acute inflammation in vivo Like 18F-FDG 18F-4FN clears rapidly through the kidney at 1 hr following iv injection
Detailed Description:
OBJECTIVES
Primary Objective
The primary objective of this first-in-human FIH study is to determine the safety biodistribution and dosimetry profile of a novel positron emission tomography PET imaging tracer 4-18Ffluoro-1-naphthol 18F4FN which specifically targets reactive oxygen species ROS A currently proposed indication for this radiopharmaceutical RP is to non-invasively quantify inflammation by PETCT imaging
Exploratory Objectives
One exploratory objective is to identify preliminary efficacy signals from PETCT images indicating that the new radiopharmaceutical localized to known or clinically-suspected tissues or regions of inflammation mediated by innate immune-related adverse events irAE Another exploratory objective is to determine if a time point other than one-hour post injection will yield clinically meaningful improvements to imaging data
Primary Objective
The primary objective of this first-in-human FIH study is to determine the safety biodistribution and dosimetry profile of a novel positron emission tomography PET imaging tracer 4-18Ffluoro-1-naphthol 18F4FN which specifically targets reactive oxygen species ROS A currently proposed indication for this radiopharmaceutical RP is to non-invasively quantify inflammation by PETCT imaging
Exploratory Objectives
One exploratory objective is to identify preliminary efficacy signals from PETCT images indicating that the new radiopharmaceutical localized to known or clinically-suspected tissues or regions of inflammation mediated by innate immune-related adverse events irAE Another exploratory objective is to determine if a time point other than one-hour post injection will yield clinically meaningful improvements to imaging data
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2022-01722 | OTHER | NCI-CTRP-Clinical Trial Reporting Registry | None |