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

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorBenjamin Viglianti

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Pregnancy

Unable to do imaging

Body weight greater than 400 lbs (181 Kg)

Prisoners are not eligible

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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-59

    Combination product

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

Treatment groups

24 Participants
are divided into 3 treatment groups
Group A: Dexamethasone (Group 2)Experimental treatment 2 interventions
Group B: Cosyntropin (Group 3)Experimental treatment 2 interventions
Group C: Adrenal pathology (Group 4)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
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.

Time frame
Day 4

Other outcomes

Sponsors and contacts

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Benjamin Viglianti

Lead sponsor

University of Michigan

Sponsor institution