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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)

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ClinicalTrials.gov Identifier: NCT04546126
Recruitment Status : Recruiting
First Posted : September 11, 2020
Last Update Posted : September 5, 2021
Sponsor:
Information provided by (Responsible Party):
Benjamin Viglianti, University of Michigan

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
Radiotracer Hypertension Cholesterol 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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)
Estimated Study Start Date : September 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. PET/CT image uptake score as measured by investigator visual assessment for each volume of interest (VOI) [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04546126


Contacts
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Contact: Jim Pool 734-615-7391 jampool@umich.edu

Locations
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United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: James Pool    734-615-7391    jampool@umich.edu   
Principal Investigator: Benjamin L Viglianti, M.D, Ph.D.         
Sponsors and Collaborators
Benjamin Viglianti
Investigators
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Principal Investigator: Benjamin L Viglianti, M.D, Ph.D. University of Michigan
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Responsible Party: Benjamin Viglianti, Assistant Professor of Radiology, University of Michigan
ClinicalTrials.gov Identifier: NCT04546126    
Other Study ID Numbers: HUM00179097b
First Posted: September 11, 2020    Key Record Dates
Last Update Posted: September 5, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Dexamethasone
Cosyntropin
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents