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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

Must not have

Subjects unable to provide own consent are not eligible

Unable to do imaging

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 4

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I can give my own consent to participate.

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I cannot undergo imaging tests.

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My body weight is over 400 lbs.

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I am currently taking steroids, birth control pills, hormone treatments, blood pressure medication, or hormone-like supplements.

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I have a diagnosed adrenal gland condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 4

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 4

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 4 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in [18F]FNP-59 chemistry uptake as measured by the standardized uptake value (SUV) based gland segmentation

Secondary study objectives

PET/CT scan

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 5Eligibility criteria met