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First-in-Human Assessment of Safety, Biodistribution and Pharmacokinetics of 18F-Fluoro-1-Naphthol (18F-4FN) for PET Imaging

Primary Purpose

Endocrine Neoplasia

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

4-[18F]Fluoro-1-Naphthol

About this trial

This is an interventional diagnostic trial for Endocrine Neoplasia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patient >/= 18 years of age.
Subject or Legal Authorized Representative (LAR) ability and willingness to sign a written informed consent.
Patients with histologic diagnosis of solid or liquid tumor treated by ICI with evidence of or clinical suspicion of irAE.
Patients seen in the Nuclear Medicine clinic for other imaging indications where innate inflammation is suspected will be eligible for the study upon consultation with Endocrine Center physicians.

Normal range standard renal and liver function tests for age:

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:

Pregnant or lactating women: pregnant women are excluded from this study because the effects of [18F]4FN in pregnancy are not known. Urine or serum pregnancy test (female </= 60 years of age or childbearing potential) within 24 hours of the PET scan.
Subjects with contraindications to the use of [18F]4FN including confirmed allergy.
Patients with a body weight of 400 pounds or more, or a BMI which precludes their entry into the bore of the PET/CT scanner, because the hardware is not intended to support that weight.
Any additional medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the physician may significantly interfere with study compliance.
Children below the age of 18 are excluded because of the unknown but potential risk of administration of radiopharmaceuticals to minors.

Sites / Locations

MD Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

4-[18F]Fluoro-1-Naphthol

Arm Description

Participants will receive 1 injection of [18F]4FN

Outcomes

Primary Outcome Measures

To identify preliminary efficacy signals from PET images that correlate with clinical foci of ICI-related irAE.

Secondary Outcome Measures

Full Information

NCT ID

NCT05335811

First Posted

February 18, 2022

Last Updated

October 13, 2023

Sponsor

M.D. Anderson Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT05335811

Brief Title

First-in-Human Assessment of Safety, Biodistribution and Pharmacokinetics of 18F-Fluoro-1-Naphthol (18F-4FN) for PET Imaging

Official Title

First-in-Human Assessment of Safety, Biodistribution and Pharmacokinetics of 18F-Fluoro-1-Naphthol (18F-4FN) for PET Imaging

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 6, 2022 (Actual)

Primary Completion Date

December 31, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

M.D. Anderson Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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 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

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-[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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Endocrine Neoplasia

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

4-[18F]Fluoro-1-Naphthol

Arm Type

Experimental

Arm Description

Participants will receive 1 injection of [18F]4FN

Intervention Type

Drug

Intervention Name(s)

4-[18F]Fluoro-1-Naphthol

Other Intervention Name(s)

[18F]4FN

Intervention Description

By vein (IV)

Primary Outcome Measure Information:

Title

To identify preliminary efficacy signals from PET images that correlate with clinical foci of ICI-related irAE.

Time Frame

through study completion, an average of 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patient >/= 18 years of age. Patients with histologic diagnosis of solid or liquid tumor treated by ICI with evidence of or clinical suspicion of irAE or patients with suspected inflammation. Normal range standard renal and liver function tests for age: 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: Pregnant or lactating women: pregnant women are excluded from this study because the effects of [18F]4FN in pregnancy are not known. Urine or serum pregnancy test (female </= 60 years of age or childbearing potential) within 24 hours of the PET scan. Subjects with contraindications to the use of [18F]4FN including confirmed allergy. Patients with a body weight of 400 pounds or more, or a BMI which precludes their entry into the bore of the PET/CT scanner, because the hardware is not intended to support that weight. Any additional medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the physician may significantly interfere with study compliance. Children below the age of 18 are excluded because of the unknown but potential risk of administration of radiopharmaceuticals to minors.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lesley Flynt, MD

Phone

(713) 745-8760

lflynt@mdanderson.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lesley Flynt, MD

Organizational Affiliation

M.D. Anderson Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

MD Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lesley Flynt, MD

First Name & Middle Initial & Last Name & Degree

Lesley Flynt, MD

12. IPD Sharing Statement

Links:

URL

http://www.mdanderson.org

Description

M D Anderson Cancer Center

Learn more about this trial

First-in-Human Assessment of Safety, Biodistribution and Pharmacokinetics of 18F-Fluoro-1-Naphthol (18F-4FN) for PET Imaging

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