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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2022-01722 | Other Identifier | NCI-CTRP-Clinical Trial Reporting Registry |
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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 species/reactive 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 i.v. injection
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-[18F]fluoro-1-naphthol ([18F]4FN), which specifically targets reactive oxygen species (ROS). A currently proposed indication for this radiopharmaceutical (RP) is to non-invasively quantify inflammation by PET/CT imaging.
Exploratory Objectives:
One exploratory objective is to identify preliminary efficacy signals from PET/CT 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4-[18F]Fluoro-1-Naphthol | Experimental | Participants will receive 1 injection of [18F]4FN |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 4-[18F]Fluoro-1-Naphthol | Drug | By vein (IV) |
|
| Measure | Description | Time Frame |
|---|---|---|
| To identify preliminary efficacy signals from PET images that correlate with clinical foci of ICI-related irAE. | through study completion, an average of 1 year |
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Inclusion Criteria:
eGFR >= 60 mL/min/1.73 m2
Adequate liver function:
Bilirubin ≤ the upper limit of normal (ULN) Alkaline phosphatase, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≤ the ULN
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sanjit Tewari, MD | Contact | (832) 729-1874 | sotewari@mdanderson.org |
| Name | Affiliation | Role |
|---|---|---|
| Sanjit Tewari, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| M D Anderson Cancer Center | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Mar 17, 2023 | Mar 11, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004700 | Endocrine System Diseases |
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