RadiotracerEarly Phase 1NCT04546126
Positron Emission Tomography (PET) Imaging of Cholesterol Trafficking: Clinical Evaluation of [18F]FNP-59 in Normal Human Subjects (Groups 2, 3 & 4)
A Early Phase 1 study testing Dexamethasone (Group 2), Cosyntropin (Group 3) and PET/CT Scan with FNP-59 in people with Radiotracer and Hypertension, run by Benjamin Viglianti at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Radiotracer, Hypertension, Cholesterol
- What is being tested?
- Dexamethasone (Group 2), Cosyntropin (Group 3) and PET/CT Scan with FNP-59
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Nov 2021to Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants without any known adrenal pathology as normal controls for undergoing endocrine manipulation
- Abnormal adrenal cortical hormone secretion
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 1 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
James Pool, 734-615-7391, jampool@umich.edu
Benjamin L Viglianti, M.D, Ph.D.
- Completed
BAMF Health, Inc.
Grand Rapids, Michigan, 49503
About this study
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.
Read the detailed 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.
- Conditions
- Radiotracer, Hypertension, Cholesterol
- Being tested
- Dexamethasone (Group 2), Cosyntropin (Group 3), PET/CT Scan with FNP-59
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone (Group 2)Drug
Participants will take 1 mg dexamethasone 2x a day for 3 days to suppress cortisol production.
Cosyntropin (Group 3)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-59Combination product
FNP-59, a radiotracer, is administered for PET/CT scans.
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone (Group 2) | Experimental | 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. Receives: Drug: Dexamethasone (Group 2); Combination Product: PET/CT Scan with FNP-59 |
| Cosyntropin (Group 3) | Experimental | 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. Receives: Drug: Cosyntropin (Group 3); Combination Product: PET/CT Scan with FNP-59 |
| Adrenal pathology (Group 4) | Experimental | 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. Receives: Combination Product: PET/CT Scan with FNP-59 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 0, Day 4
Secondary outcomes (1)
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.
Measured: Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2020
- Study start1 Nov 2021
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RadiotracerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benjamin Viglianti
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Benjamin Viglianti, University of Michigan
- Investigators
- Benjamin L Viglianti, M.D, Ph.D., Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04546126
- Sponsor's protocol ID
- HUM00179097b
- Status last verified
- Nov 2025
- First submitted
- 8 Sep 2020
- Last updated
- 5 Dec 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positron Emission Tomography (PET) Imaging of Cholesterol Trafficking: Clinical Evaluation of [18F]FNP-59 in Normal Human Subjects (Groups 2, 3 & 4)
- ClinicalTrials.gov ID
- NCT04546126
- Acronym / sponsor ID
- HUM00179097b
- Conditions
- Radiotracer, Hypertension, Cholesterol
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Benjamin VigliantiUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 11 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone (Group 2) | Experimental | Drug: Dexamethasone (Group 2), Combination Product: PET/CT Scan with FNP-59Participants 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. |
| Cosyntropin (Group 3) | Experimental | Drug: Cosyntropin (Group 3), Combination Product: PET/CT Scan with FNP-59Participants 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. |
| Adrenal pathology (Group 4) | Experimental | Combination Product: PET/CT Scan with FNP-59Whole-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants without any known adrenal pathology as normal controls for undergoing endocrine manipulation
- Abnormal adrenal cortical hormone secretion
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone (Group 2)Participants will take 1 mg dexamethasone 2x a day for 3 days to suppress cortisol production. | Drug | Dexamethasone (Group 2) |
| 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. | Drug | Cosyntropin (Group 3) |
| PET/CT Scan with FNP-59FNP-59, a radiotracer, is administered for PET/CT scans. | Combination product | Adrenal pathology (Group 4), Cosyntropin (Group 3), Dexamethasone (Group 2) |
Primary outcome
Change in [18F]FNP-59 chemistry uptake as measured by the standardized uptake value (SUV) based gland segmentation
Time frame: Day 0, Day 4
SUV will be reported. Both maximal and average SUVs will be calculated
1 secondary outcome
PET/CT image uptake score as measured by investigator visual assessment for each volume of interest (VOI)
Time frame: Day 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Benjamin L Viglianti, M.D, Ph.D. principal investigator
University of Michigan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Dexamethasone (Group 2), Cosyntropin (Group 3) and PET/CT Scan with FNP-59 in people with Radiotracer and Hypertension, run by Benjamin Viglianti at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jim Pool (734-615-7391, jampool@umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in [18F]FNP-59 chemistry uptake as measured by the standardized uptake value (SUV) based gland segmentation (time frame: Day 0, Day 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.