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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Radiotracer Hypertension Cholesterol

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Dexamethasone (Group 2)

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.

Group Type EXPERIMENTAL

Dexamethasone (Group 2)

Intervention Type DRUG

Participants will take 1 mg dexamethasone 2x a day for 3 days to suppress cortisol production.

PET/CT Scan with FNP-59

Intervention Type COMBINATION_PRODUCT

FNP-59, a radiotracer, is administered for PET/CT scans.

Cosyntropin (Group 3)

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.

Group Type EXPERIMENTAL

Cosyntropin (Group 3)

Intervention Type DRUG

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.

PET/CT Scan with FNP-59

Intervention Type COMBINATION_PRODUCT

FNP-59, a radiotracer, is administered for PET/CT scans.

Adrenal pathology (Group 4)

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.

Group Type EXPERIMENTAL

PET/CT Scan with FNP-59

Intervention Type COMBINATION_PRODUCT

FNP-59, a radiotracer, is administered for PET/CT scans.

Interventions

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Dexamethasone (Group 2)

Participants will take 1 mg dexamethasone 2x a day for 3 days to suppress cortisol production.

Intervention Type DRUG

Cosyntropin (Group 3)

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.

Intervention Type DRUG

PET/CT Scan with FNP-59

FNP-59, a radiotracer, is administered for PET/CT scans.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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Inclusion Criteria

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

* Abnormal adrenal cortical hormone secretion

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

* Pregnant

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes