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FNP-59 for High Cholesterol

Phase < 1
Recruiting
Led By Ben Viglianti, M.D, Ph.D.
Research Sponsored by Benjamin Viglianti
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0
Awards & highlights

Study Summary

This trial will test a new imaging agent to see if it can help doctors better visualize the adrenal gland. This could lead to improved treatment of adrenal gland disorders.

Who is the study for?
This trial is for healthy individuals without any adrenal gland issues. They must not be pregnant, imprisoned, or unable to consent. Participants should not be on steroids, certain blood pressure medications (ACE inhibitors/ARBs), hormone treatments like oral contraceptives, or weigh over 400 lbs.Check my eligibility
What is being tested?
[18F]FNP-59 is being tested as a new PET imaging agent that could potentially provide clearer images of the adrenal glands with less radiation exposure compared to current methods. This phase 0 study involves a single sub-therapeutic dose in normal subjects.See study design
What are the potential side effects?
As this is an initial test of [18F]FNP-59 in humans primarily for imaging purposes and uses a sub-therapeutic dose, specific side effects are unknown but may include reactions at the injection site or allergic responses.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Uptake for [18F]FNP-59 in the adrenal glands using the standardized uptake value (SUV) based on gland segmentation

Trial Design

1Treatment groups
Experimental Treatment
Group I: Group 1Experimental Treatment1 Intervention
These subjects, 6 planned (3 male, 3 female), will be to obtain normal tissue distribution of [18F]NP-59 and confirm calculated radiation dosimetry and optimal uptake time.

Find a Location

Who is running the clinical trial?

Benjamin VigliantiLead Sponsor
1 Previous Clinical Trials
24 Total Patients Enrolled
Ben Viglianti, M.D, Ph.D.Principal InvestigatorUniversity of Michigan

Media Library

Group 1 Clinical Trial Eligibility Overview. Trial Name: NCT04532489 — Phase < 1
High Cholesterol Research Study Groups: Group 1
High Cholesterol Clinical Trial 2023: Group 1 Highlights & Side Effects. Trial Name: NCT04532489 — Phase < 1
Group 1 2023 Treatment Timeline for Medical Study. Trial Name: NCT04532489 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Michigan
What site did they apply to?
University of Michigan
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Positron Emission Tomography (PET) Imaging of Cholesterol Trafficking: Clinical Evaluation of [18F]FNP-59 in Normal Human Subjects (Group 1)
Benjamin Viglianti 2021. "Positron Emission Tomography (PET) Imaging of Cholesterol Trafficking: Clinical Evaluation of [18F]FNP-59 in Normal Human Subjects (Group 1)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04532489.
All > Hypertension > Cholesterol
~1 spots leftby Dec 2024
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