Positron Emission Tomography (PET) Imaging of Cholesterol Trafficking: Clinical Evaluation of [18F]FNP-59 in Normal Human Subjects (Groups 2, 3 & 4)

Benjamin Viglianti

Status and phase: Enrolling; Early Phase 1

Conditions: Hypertension; Cholesterol; Radiotracer

Treatments: Drug: Cosyntropin (Group 3); Combination Product: PET/CT Scan with FNP-59; Drug: Dexamethasone (Group 2)

Study type: Interventional

Funder types: Other

Identifiers

NCT04546126

HUM00179097b

Details and patient eligibility

About

This 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. Some participants are healthy normal subjects but have undergone interventions to manipulate hormones while other participants have known adrenal pathology.

Full description

Groups 2 & 3 used hormone manipulation using information gathered from Group 1 which identified radiation dosimetry and optimal uptake time.

Group 4 (added to the study later) includes participants with known adrenal pathology. They will not have study associated hormone manipulation.

All groups will be given a radio-tracer and PET/CT scans.

The researchers believe that a fluorine-18 analogue of NP-59, [18F]FNP-59, would greatly improve the imaging characteristics, by providing a PET imaging cholesterol analogue with significantly improved radiation dosimetry, and improved localization / sensitivity / specificity without concern of thyroid exposure.

Enrollment: 24 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria (Groups 2 & 3):

• Participants without any known adrenal pathology as normal controls for undergoing endocrine manipulation

Exclusion Criteria (Groups 2 & 3):

• 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

Inclusion Criteria (Group 4):

• Abnormal adrenal cortical hormone secretion

Exclusion Criteria (Group 4):

• Pregnant

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

Dexamethasone (Group 2)

Experimental group

Description:

Participants will undergo an FNP-59 scan on day 0 in the am. Participants will then take 1 mg dexamethasone 2x a day for 3 days to suppress cortisol production. Participants will then have a second FNP-59 scan on day 4 in the am.

Treatment:

Drug: Dexamethasone (Group 2)

Combination Product: PET/CT Scan with FNP-59

Cosyntropin (Group 3)

Experimental group

Description:

Participants will undergo an FNP-59 scan on day 0 in the am. On day 4 the participant will arrive for imaging. Cosyntropin, 250 micro-gm will be administered IV. Five minutes following administration FNP-59 will be given. Following uptake of FNP-59 imaging will occur.

Treatment:

Combination Product: PET/CT Scan with FNP-59

Drug: Cosyntropin (Group 3)

Adrenal pathology (Group 4)

Experimental group

Description:

Whole-body PET/CT scans will be done on 4 patients at 1 hr and the other 4 patients at 6 hours. All the patients will have a whole-body PET/CT scan at 3 hours.

Treatment:

Combination Product: PET/CT Scan with FNP-59