PET Imaging of Natriuretic Peptide Receptor C (NPR-C) in Carotid Atherosclerosis (Volunteer - BioD and Safety Study)

NCT02498379 | Completed Early Phase 1

• 1 other identifier: 201409006V
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to assess the safety, biodistribution and dosimetry of the novel atherosclerotic imaging PET radiotracer, Cu\[64\]-25%-CANF-Comb.

Conditions

Atherosclerosis

Keywords

novel radiotracer; biodistribution; safety

Outcome Measures

Primary Outcomes (1)

• Biodistribution, dosimetry and safety of Cu[64]-25%CANF-Comb in normal healthy adult volunteers.

  Biodistribution by PET-CT (Cu\[64\]-25%CANF-Comb uptake in blood, liver, kidneys, spleen, heart, bone, muscle); Amount of radioactive tracer in the blood and urine; Difference in physical examination findings, vital signs, serum and urine laboratory values and EKG results from baseline.

  24-48 hours

Study Arms (1)

Cu[64]-25%CANF-Comb

EXPERIMENTAL

Single IV injection of 4-8 mCi Cu\[64\]-25%CANF-Comb followed by PET-CT scan at 1-4 hours, 5-10 hours, and 22-26 hours or 46-50 hours post injection.

Drug: Cu[64]-25%CANF-Comb

Interventions

Cu[64]-25%CANF-Comb DRUG

Intravenous injection of 4-8 mCi of Cu\[64\]-25%CANF-Comb with PET-CT scans performed 1-4 hours, 5-10 hours, and 22-26 hours or 46-50 hours after injection.

Cu[64]-25%CANF-Comb

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteers (4 men and 4 women)
• No evidence of cardiovascular disease and not under care of a physician for any active medical condition
• Health status confirmed by physical exam and ECG
• Signed informed consent

You may not qualify if:

• Pregnancy or lactation
• Inability to lie still for up to 60 min with arms above head for PET-CT imaging
• Unwilling to comply with study procedures and unavailable for the duration of the study.
• Inability to provide written informed consent.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University in St.Louis

St Louis, Missouri, 63110, United States

Location

Related Publications (2)

• Liu Y, Pressly ED, Abendschein DR, Hawker CJ, Woodard GE, Woodard PK, Welch MJ. Targeting angiogenesis using a C-type atrial natriuretic factor-conjugated nanoprobe and PET. J Nucl Med. 2011 Dec;52(12):1956-63. doi: 10.2967/jnumed.111.089581. Epub 2011 Nov 2.

  PMID: 22049461 BACKGROUND

• Liu Y, Abendschein D, Woodard GE, Rossin R, McCommis K, Zheng J, Welch MJ, Woodard PK. Molecular imaging of atherosclerotic plaque with (64)Cu-labeled natriuretic peptide and PET. J Nucl Med. 2010 Jan;51(1):85-91. doi: 10.2967/jnumed.109.066977. Epub 2009 Dec 15.

  PMID: 20008978 BACKGROUND

MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Pamela K Woodard, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: July 6, 2015
• First Posted: July 15, 2015
• Study Start: October 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: April 28, 2016

Record last verified: 2016-04

Locations

US (1)