Imaging of Cannabinoid Receptors Using New Radioactive Tracer

NCT00450021 | Completed Phase 1

• 2 other identifiers: 07011807-M-0118
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This study will test a new radioactive tracer, \[(11)C\]MePPEP, for use in positron emission tomography (PET) imaging. The tracer is used to visualize cannabinoid receptors, proteins in the brain that mediate a variety of natural chemicals. These receptors may be important in behavioral diseases such as addiction, obesity and psychiatric diseases. Healthy normal volunteers between 18 and 65 years of age may be eligible for this study. Ten participants undergo whole body PET imaging to determine where the \[(11)C\]MePPEP tracer is distributed in the body in order to calculate radiation exposure from the tracer. Another 10 subjects undergo brain imaging with \[(11)C\]MePPEP to measure cannabinoid receptors in the brain. All participants are evaluated with a medical history and physical examination, blood and urine tests and an electrocardiogram (ECG) before scanning. They then have a PET scan. For this procedure, a catheter (plastic tube) is placed in a vein in the arm through which the tracer is injected. A special mask is fitted to the head and attached to the bed to help keep the head in place during the scan. Subjects undergoing brain imaging also have a catheter placed in an artery in the wrist from which blood samples are collected during the procedure. The scan lasts about 2 to 2.5 hours. Subjects undergoing brain imaging also have magnetic resonance imaging (MRI) within 1 year of the PET scan. For MRI, the subject lies on a bed that moves into the tubular scanner, wearing earplugs to protect the ears from loud noises that occur during the scan. The procedure takes about 1 hour.

Conditions

Healthy

Keywords

PET; CB1 Receptor; Cannabinoid; [11C] MePPEP; Brain Imaging; Healthy Volunteer; HV

Outcome Measures

Primary Outcomes (1)

• Efficacy of novel PET tracer for DB! in Brain imaging.

Secondary Outcomes (1)

• Safety and radiation dosimetry of PET tracer [11C] MePPEP; Distribution and variance of CB1 receptors in the brain of healthy controls

Interventions

[(11)C] MePPEP DRUG

Eligibility Criteria

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

You may qualify if:

• All subjects must be healthy and aged 18-65 years, with history/physical exam, ECG, and laboratory tests within one year of the PET scan. The volunteer must sign an informed consent form.

You may not qualify if:

• Current psychiatric illness, substance abuse including marijuana use, or severe systemic disease based on history and physical exam.
• Laboratory tests with clinically significant abnormalities or positive urine toxicology screen.
• Prior participation in other research protocols in the last year such that radiation exposure would exceed the annual limits.
• Pregnancy and breast feeding.
• Claustrophobia.
• Presence of ferromagnetic metal in the body or heart pacemaker.
• Positive HIV test.
• Employee of the investigative site or an immediate family member of an employee of the investigative site. Immediate family member is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
• Employee of Eli Lilly and Company.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): lead
• National Institute of Mental Health, Eli Lilly & Co.: collaborator

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

• Carson RE, Huang SC, Green MV. Weighted integration method for local cerebral blood flow measurements with positron emission tomography. J Cereb Blood Flow Metab. 1986 Apr;6(2):245-58. doi: 10.1038/jcbfm.1986.38.

  PMID: 3485644 BACKGROUND

MeSH Terms

Interventions

Carbon-11

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH

Study Record Dates

• First Submitted: March 20, 2007
• First Posted: March 21, 2007
• Study Start: March 19, 2007
• Primary Completion: February 6, 2008
• Last Updated: July 2, 2017

Record last verified: 2008-02-06

Locations

US (1)