Positron Emission Tomography (PET) Imaging of Cholesterol Trafficking: Clinical Evaluation of [18F]FNP-59 in Normal Human Subjects (Group 1)

Benjamin Viglianti

Status and phase: Enrolling; Early Phase 1

Conditions: Hypertension; Cholesterol; Radiotracer

Treatments: Drug: FNP-59

Study type: Interventional

Funder types: Other

Identifiers

NCT04532489

HUM00179097a

Details and patient eligibility

About

This exploratory, first-in-man, phase 0 study will evaluate the feasibility of using a sub-therapeutic dose of a fluorine-18 analogue of NP-59 ([18F]FNP-59) to image the adrenal gland in healthy normal subjects. The researchers believe that [18F]FNP-59 would greatly improve the imaging characteristics, by providing a PET imaging cholesterol analogue with significantly improved radiation dosimetry.

Full description

Following the results of radiation dosimetry from this study then next steps will be taken for groups 2 & 3 using hormone manipulation.

Enrollment: 6 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participants without any known adrenal pathology as normal controls for radiation dosimetry purposes

Exclusion criteria

• Pregnancy
• Unable to do imaging
• Body weight greater than 400 lbs (181 Kg)
• Prisoners are not eligible
• Subjects unable to provide own consent are not eligible
• Current use of steroids, Oral contraceptives (OCP), spironolactone, estrogen, androgen, progesterone, Angiotensin-converting enzyme (ACE inhibitors)/ Angiotensin II receptor blockers (ARBs), or supplements that are hormone analogues.
• Known adrenal pathology

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Group 1

Other group

Description:

These subjects, 6 planned (3 male, 3 female), will be to obtain normal tissue distribution of \[18F\]NP-59 and confirm calculated radiation dosimetry and optimal uptake time.

Treatment:

Drug: FNP-59