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

Study Overview
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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.

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.

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

Conditions
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Radiotracer, Hypertension, Cholesterol

Intervention / Treatment
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* Drug: Dexamethasone (Group 2)
* Drug: Cosyntropin (Group 3)
* Combination Product: PET/CT Scan with FNP-59


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexamethasone (Group 2)<br>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. | Drug: Dexamethasone (Group 2)<br>* Participants will take 1 mg dexamethasone 2x a day for 3 days to suppress cortisol production.<br>Combination Product: PET/CT Scan with FNP-59<br>* FNP-59, a radiotracer, is administered for PET/CT scans.<br>|
| Experimental: Cosyntropin (Group 3)<br>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. | Drug: Cosyntropin (Group 3)<br>* 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.<br>Combination Product: PET/CT Scan with FNP-59<br>* FNP-59, a radiotracer, is administered for PET/CT scans.<br>|
| Experimental: Adrenal pathology (Group 4)<br>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. | Combination Product: PET/CT Scan with FNP-59<br>* FNP-59, a radiotracer, is administered for PET/CT scans.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in [18F]FNP-59 chemistry uptake as measured by the standardized uptake value (SUV) based gland segmentation | SUV will be reported. Both maximal and average SUVs will be calculated | Day 0, Day 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PET/CT image uptake score as measured by investigator visual assessment for each volume of interest (VOI) | Investigator scoring system (no increased uptake = 0, mild uptake = 1, moderate uptake = 2, high uptake = 3, relative to background. Higher scores indicate increased uptake. | Day 4 |