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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04546126
• Other study ID #: HUM00179097b
• Status: Recruiting
• Phase: Early Phase 1
• Start date: November 1, 2021
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: University of Michigan
• Contact: Jim Pool
• Phone: 734-615-7391
• Email: jampool[@]umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cholesterol
• Hypertension
• Radiotracer

Intervention

Drug:
• Dexamethasone (Group 2)
Participants will take 1 mg dexamethasone 2x a day for 3 days to suppress cortisol production.
• 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.

Combination Product:
• PET/CT Scan with FNP-59
FNP-59, a radiotracer, is administered for PET/CT scans.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	BAMF Health, Inc.	Grand Rapids	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Benjamin Viglianti

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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