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PET Imaging with FNP-59
Phase < 1
Recruiting
Led By Benjamin L 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 4
Awards & highlights
Study Summary
This trial will test if a low dose of a fluorine-18-based NP-59 can be used to image the adrenal gland in healthy people and people with adrenal conditions.
Who is the study for?
This trial is for healthy individuals without adrenal gland issues, who will undergo hormone manipulation, or those with abnormal adrenal hormone secretion. It's not for pregnant women, prisoners, people over 400 lbs, steroid users, or those on certain medications like OCPs and ACE inhibitors.Check my eligibility
What is being tested?
The study tests a new PET/CT scan using [18F]FNP-59 to image the adrenal gland. Some participants will also receive Cosyntropin (Group 3) or Dexamethasone (Group 2) to see how these drugs affect imaging results.See study design
What are the potential side effects?
Potential side effects may include reactions related to the PET/CT scan procedure and discomfort from injections of Cosyntropin or Dexamethasone. The specific side effects of [18F]FNP-59 are not detailed but could be similar to other imaging agents.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 4
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 4
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in [18F]FNP-59 chemistry uptake as measured by the standardized uptake value (SUV) based gland segmentation
Secondary outcome measures
PET/CT scan
Trial Design
3Treatment groups
Experimental Treatment
Group I: Dexamethasone (Group 2)Experimental Treatment2 Interventions
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.
Group II: Cosyntropin (Group 3)Experimental Treatment2 Interventions
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.
Group III: Adrenal pathology (Group 4)Experimental Treatment1 Intervention
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.
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Who is running the clinical trial?
Benjamin VigliantiLead Sponsor
1 Previous Clinical Trials
6 Total Patients Enrolled
Benjamin L Viglianti, M.D, Ph.D.Principal InvestigatorUniversity of Michigan
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Research Study Groups:
This trial has the following groups:- Group 1: Dexamethasone (Group 2)
- Group 2: Adrenal pathology (Group 4)
- Group 3: Cosyntropin (Group 3)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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