Imaging of CB1 Receptors Using (11C)SD5024

NCT01399398 | Terminated Phase 1

• 2 other identifiers: 11020211-M-0202
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Background: \- The cannabinoid type 1 (CB1) receptor is a protein found on some brain cells. It may play a role in obesity or some psychiatric disorders such as schizophrenia. Imaging studies like positron emission tomography (PET) can show where CB1 receptors are located. A new radioactive chemical, 11C-SD5024, may be able to show these receptors more clearly than previous radioactive chemicals. Better images of CB1 receptors in the brain may help improve our understanding of obesity and psychiatric disorders. This information may lead to better treatments. Objectives: \- To test how well a new radioactive chemical, 11C-SD5024, is taken up by the brain during imaging studies. Eligibility: \- Healthy volunteers between 18 and 50 years of age who are able to have positron emission tomography scans. Design:

• All participants will be screened with a physical exam, medical history, and blood tests.
• Participants will be in one of three groups for the study. Each group will receive 11C-SD5024 and have a different set of imaging studies.
• Group 1 will have a magnetic resonance imaging (MRI) scan and PET scan of the brain. They will also have blood and urine tests.
• Group 2 will have a whole-body PET scan, as well as blood and urine tests.
• Group 3 will have an MRI scan of the brain, followed by two PET scans of the brain. They will also have blood and urine tests. The two PET scans can happen on the same day or on two different days.

Conditions

Healthy

Keywords

Brain Scan; Kinetic Analysis; Healthy Subjects; Healthy Volunteer; HV

Outcome Measures

Primary Outcomes (1)

• For the PET scans, we will measure the regional densities of cannabinoid 1 receptors as distribution volume (VT). Distribution volume is the ratio at equilibrium of brain uptake to the concentration of parent radioligand in plasma.

Interventions

Brain Scan-MRI PROCEDURE

Arterial Line PROCEDURE

Brain Scan-PET PROCEDURE

Venous Line PROCEDURE

Blood Sampling PROCEDURE

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy control subjects aged 18 50 whose medical history, physical exam, electrocardiogram (ECG), and laboratory test results are within normal limits within one year of the PET scan will be eligible to participate.

You may not qualify if:

• Any recent or past history of psychiatric illness or severe systemic disease based on history and physical exam.
• Serious medical illness likely to modify brain anatomy and/or physiology (head trauma, past brain surgery, neurological disorders such as epilepsy, Parkinson disease, and psychiatric disorders such as schizophrenia and depression)
• Any current substance or alcohol abuse, with the exception of nicotine.
• Positive urine toxicology screen
• Radiation exposure from participation in other research protocols in the last year such that the additional radiation exposure from this protocol would exceed annual limits.
• Pregnant or breastfeeding.
• Claustrophobia (applies to Parts 1 and 3 only).
• Metallic (ferromagnetic) implants, including pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pump, shrapnel fragments, and possible small metal fragments in the eye (applies to Parts 1 and 3 only).
• Unable to lie flat on back for up to 2.5 hours.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Burger C, Buck A. Requirements and implementation of a flexible kinetic modeling tool. J Nucl Med. 1997 Nov;38(11):1818-23.

  PMID: 9374364 BACKGROUND

• Cloutier RJ, Smith SA, Watson EE, Snyder WS, Warner GG. Dose to the fetus from radionuclides in the bladder. Health Phys. 1973 Aug;25(2):147-61. doi: 10.1097/00004032-197308000-00009. No abstract available.

  PMID: 4784245 BACKGROUND

• Donohue SR, Pike VW, Finnema SJ, Truong P, Andersson J, Gulyas B, Halldin C. Discovery and labeling of high-affinity 3,4-diarylpyrazolines as candidate radioligands for in vivo imaging of cannabinoid subtype-1 (CB1) receptors. J Med Chem. 2008 Sep 25;51(18):5608-16. doi: 10.1021/jm800329z.

  PMID: 18754613 BACKGROUND

MeSH Terms

Interventions

Vascular Access Devices; Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Catheters; Equipment and Supplies; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Masahiro Fujita, M.D.

  National Institute of Mental Health (NIMH)

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 20, 2011
• First Posted: July 21, 2011
• Study Start: June 22, 2011
• Primary Completion: December 18, 2013
• Study Completion: December 18, 2013
• Last Updated: November 29, 2019

Record last verified: 2013-12-18

Locations

US (1)