Protocol Details

PET Imaging of CB1 Receptors Using [11C]SD5024

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number	11-M-0202
Sponsoring Institute	National Institute of Mental Health (NIMH)
Recruitment Detail	Type: Participants currently recruited/enrolled Gender: Male & Female Min Age: 18 Max Age: 50
Referral Letter Required	No
Population Exclusion(s)	Children
Special Instructions	Currently Not Provided
Keywords	Brain Scan; Kinetic Analysis; Healthy Subjects
Recruitment Keyword(s)	Healthy Volunteer; HV
Condition(s)	Healthy
Investigational Drug(s)	[(11)C]SD5024
Investigational Device(s)	None
Intervention(s)	Procedure/Surgery: Brain Scan-PET Procedure/Surgery: Brain Scan-MRI Procedure/Surgery: Arterial Line Procedure/Surgery: Venous Line Procedure/Surgery: Blood Sampling
Supporting Site	National Institute of Mental Health

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.

--Back to Top--

Eligibility

INCLUSION CRITERIA:

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.

EXCLUSION CRITERIA:

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.

--Back to Top--

Citations:

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

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.

Donohue SR, Pike VW, Finnema SJ, Truong P, Andersson J, Guly‡s 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.

--Back to Top--

Contacts:

Principal Investigator	Referral Contact	For more information:
Masahiro Fujita, M.D. National Institute of Mental Health (NIMH) National Institutes of Health Building 31 Room B2B37 31 Center Drive Bethesda, Maryland 20892 (301) 451-8898 fujitam@intra.nimh.nih.gov	Maria D. Ferraris Araneta, C.R.N.P. National Institute of Mental Health (NIMH) National Institutes of Health BG 10 RM B1D43 MSC 1026 10 CENTER DR BETHESDA MD 20892-1026 (301) 496-9423 ferrarism@mail.nih.gov	Patient Recruitment and Public Liaison Office Building 61 10 Cloister Court Bethesda, Maryland 20892-4754 Toll Free: 1-800-411-1222 TTY: 301-594-9774 (local),1-866-411-1010 (toll free) Fax: 301-480-9793 prpl@mail.cc.nih.gov

Clinical Trials Number:

NCT01399398

--Back to Top--

QUESTIONS?

Contact the Patient Recruitment and Public Liaison Office for:

• Details on how to participate in a study
• Details on how to refer a patient to a study

NIH Clinical Studies Information Request

---

Contact the Office of Communications for:

• General information about the NIH Clinical Center

www.cc.nih.gov/contact.shtml

---

Contact the Department Clinical Research Informatics, (DCRI) for:

• Technical questions about Adobe Acrobat and the PDF format
• Technical questions about this web server

webmaster@cc.nih.gov