Neoplasms

Gland and Hormone Related Diseases

All Conditions

Endocrine Gland Neoplasms

Endocrine System Diseases

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

4-[18F]Fluoro-1-Naphthol

Lesley Flynt, MD

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.

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

M.D. Anderson Cancer Center

Symptoms and General Pathology

Rare Diseases

Syndrome

Cushing Syndrome

Pheochromocytoma

Death

Hyperaldosteronism

Death, Sudden

Paraganglioma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Adrenocortical Hyperfunction

Adrenal Gland Diseases

Cushing's Syndrome

Paragangliomas 1

Neuroendocrine Tumor

Neuroepithelioma

Hyperadrenalism

Anti-Inflammatory Agents

All Drugs and Chemicals

Vasoconstrictor Agents

Respiratory System Agents

Hydrocortisone

Hydrocortisone 17-butyrate 21-propionate

Hydrocortisone acetate

Hydrocortisone hemisuccinate

Epinephrine

Racepinephrine

Epinephryl borate

Adrenergic Agents

Adrenergic alpha-Agonists

Adrenergic Agonists

Neurotransmitter Agents

Adrenergic beta-Agonists

Bronchodilator Agents

Anti-Asthmatic Agents

Mydriatics

Sympathomimetics

Unexpected witnessed death occurring within an hour of the onset of symptoms in a person with or without previously known cardiac disease without an extra-cardiac cause, or unexpected unwitnessed death without extra-cardiac cause occurring in the previous 24 hours

Death because of an exogenic reason for sudden death such as trauma or suicide as a control group i.e. non-disease-induced sudden death

Immunoshistochemical diagnosis of primary aldosteronism

Adrenal aldosterone synthase (CYP11B2) staining

Immunoshistochemical diagnosis of adrenal hypercortisolism

Adrenal cortisol synthase (CYP11B1) staining

Diagnosis of any endocrine neoplasia other than primary aldosteronism or adrenal hypercortisolism

Histopathological analysis

Niina Matikainen, MD, PhD, Assoc Prof

Sudden Cardiac Death is a leading cause of mortality and remains a major public health burden worldwide. Cardiac arrest due to coronary heart disease explains a large proportion of the cases, but if autopsy is not performed the exact underlying cause remains obscure in many adults who face sudden death outside heath care organizations. The investigators aim to find proof that primary aldosteronism is a risk factor for sudden death and to characterize the prevalence of adrenal pathology in sudden death of undetermined cause in a case-control study. In addition, the study aims to characterize the prevalence of other adrenal pathology i.e. silent adenomas, cortisol-producing adenomas and pheochromocytomas in sudden death. The investigators also seek evidence that other endocrine hormone overproduction-causing diseases are more prevalent in persons with sudden death compared with those experiencing traumatic or suicidal death sudden death.

Postmortem Evaluation of Adrenal and Other Endocrine Tumors in Patients With Sudden Death

Postmortem Evaluation of Adrenal and Other Endocrine Tumors in Patients With Sudden Death Without Definitive Causative Diagnosis (PEA-SuddenDeath)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
First-in-Human Assessment of Safety, Biodistribution and Pharmacokinetics of 18F-Fluoro-1-Naphthol (18F-4FN) for PET Imaging	NCT05335811	Endocrine Neopl...	4-[18F]Fluoro-1...	18 Years -	M.D. Anderson Cancer Center
Postmortem Evaluation of Adrenal and Other Endocrine Tumors in Patients With Sudden Death	NCT05446779	Primary Aldoste... Adrenal Cushing... Pheochromocytom... Endocrine Neopl...	Adrenal aldoste... Adrenal cortiso... Histopathologic...	35 Years - 70 Years	Helsinki University Central Hospital

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