NCT02385877

Brief Summary

The purpose of this study is to perform first-in-human PET imaging studies of two new cardiac sympathetic nerve imaging agents, 4-\[18F\]fluoro-meta-hydroxyphenethylguanidine (\[18F\]4F-MHPG) and 3-\[18F\]fluoro-para-hydroxyphenethylguanidine (\[18F\]3F-PHPG).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2015

Completed
4 days until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 11, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

July 2, 2017

Status Verified

June 1, 2017

Enrollment Period

1.4 years

First QC Date

February 25, 2015

Last Update Submit

June 30, 2017

Conditions

Autonomic Peripheral Nervous System Diseases

Outcome Measures

Primary Outcomes (1)

  • Composite measure based on radiotracer tissue uptake ratios (heart-to-lung ratio, heart-to-liver ratio, heart-to-blood ratio) and rates of metabolism in plasma (half-time, in minutes) of [18F]4F-MHPG and [18F]3F-PHPG in healthy subjects.

    These data will be used to select the lead radiotracer for further clinical development.

    3 months

Secondary Outcomes (2)

  • Radiation Dose

    1 year

  • Number of Adverse Events

    30 days

Study Arms (3)

Protocol 1: [18F]4F-MHPG

EXPERIMENTAL

Subjects (n = 4) will be injected one time with 6.5 mCi of 4-\[18F\]fluoro-meta-hydroxyphenethylguanidine (\[18F\]4F-MHPG) and receive a 90 minute PET scan.

Drug: [18F]4F-MHPG

Protocol 1: [18F]3F-PHPG

EXPERIMENTAL

Subjects (n = 4) will be injected one time with 6.5 mCi of 3-\[18F\]fluoro-para-hydroxyphenethylguanidine (\[18F\]3F-PHPG) and receive a 90 minute PET scan.

Drug: [18F]3F-PHPG

Protocol 2: Biodistribution Studies

EXPERIMENTAL

Subjects (n = 4) will be injected one time with 6.5 mCi of either \[18F\]4F-MHPG or \[18F\]3F-PHPG (whichever is selected based on Protocol 1 studies) and receive four whole-body PET scans, starting at 5 min, 60 min, 150 min and 360 min after tracer injection.

Drug: [18F]4F-MHPGDrug: [18F]3F-PHPG

Interventions

[18F]4F-MHPGDRUG

IV injection of \[18F\]4F-MHPG

Also known as: 4-[18F]fluoro-meta-hydroxyphenethylguanidine
Protocol 1: [18F]4F-MHPGProtocol 2: Biodistribution Studies
[18F]3F-PHPGDRUG

IV injection of \[18F\]3F-PHPG

Also known as: 3-[18F]fluoro-para-hydroxyphenethylguanidine
Protocol 1: [18F]3F-PHPGProtocol 2: Biodistribution Studies

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Non-obese (BMI \< 30)
  • Normal blood pressure
  • Normal blood lipid profile
  • No history of prior cardiovascular disease
  • Not susceptible to claustrophobia
  • Ability to lay flat for 90 min

You may not qualify if:

  • Obesity (BMI \> 30)
  • Risk factors for heart disease (age \> 55y, hypertension, smoking, high blood pressure, high cholesterol levels, diabetes, etc.)
  • History of heart disease (heart attack, atrial fibrillation, ventricular tachycardia, exertional angina)
  • Currently using certain medications that may interact with cardiac nerves (antidepressants, cold medications, nasal decongestants, monoamine oxidase inhibitors, etc.)
  • Claustrophobia
  • Inability to lie flat for 90 min
  • Pregnant or breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

  • Raffel DM, Jung YW, Koeppe RA, Jang KS, Gu G, Scott PJH, Murthy VL, Rothley J, Frey KA. First-in-Human Studies of [18F] Fluorohydroxyphenethylguanidines. Circ Cardiovasc Imaging. 2018 Dec;11(12):e007965. doi: 10.1161/CIRCIMAGING.118.007965.

    PMID: 30558502DERIVED

MeSH Terms

Conditions

Autonomic Nervous System Diseases

Interventions

4-fluoro-3-hydroxyphenethylguanidine

Condition Hierarchy (Ancestors)

Nervous System Diseases

Study Officials

  • David M Raffel, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Associate Professor

Study Record Dates

First Submitted

February 25, 2015

First Posted

March 11, 2015

Study Start

March 1, 2015

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

July 2, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)