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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)

Sponsor
Benjamin Viglianti (Other)
Overall Status
Recruiting
CT.gov ID
NCT04546126
Collaborator
(none)
24
Enrollment
1
Location
3
Arms
13
Anticipated Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Dexamethasone (Group 2)
  • Drug: Cosyntropin (Group 3)
  • Combination Product: PET/CT Scan with FNP-59
 Early Phase 1

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

Study Type:
Interventional
Anticipated Enrollment :
24 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Positron Emission Tomography (PET) Imaging of Cholesterol Trafficking: Clinical Evaluation of [18F]FNP-59 in Normal Human Subjects (Groups 2, 3 & 4)
Actual Study Start Date :
Nov 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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

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

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.

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

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

Outcome Measures

Primary Outcome Measures

  1. Change in [18F]FNP-59 chemistry uptake as measured by the standardized uptake value (SUV) based gland segmentation [Day 0, Day 4]

    SUV will be reported. Both maximal and average SUVs will be calculated

Secondary Outcome Measures

  1. PET/CT image uptake score as measured by investigator visual assessment for each volume of interest (VOI) [Day 4]

    Investigator scoring system (no increased uptake = 0, mild uptake = 1, moderate uptake = 2, high uptake = 3, relative to background. Higher scores indicate increased uptake.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Michigan Ann Arbor Michigan United States 48109

Sponsors and Collaborators

  • Benjamin Viglianti

Investigators

  • Principal Investigator: Benjamin L Viglianti, M.D, Ph.D., University of Michigan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Benjamin Viglianti, Assistant Professor of Radiology, University of Michigan
ClinicalTrials.gov Identifier:
NCT04546126
Other Study ID Numbers:
  • HUM00179097b
First Posted:
Sep 11, 2020
Last Update Posted:
Feb 1, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Hypertension
Dexamethasone
Cosyntropin

Study Results

No Results Posted as of Feb 1, 2022