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Protocol Details

Assessment of [11C]DPA-713 in Temporal Lobe Epilepsy

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

13-M-0070

Sponsoring Institute

National Institute of Mental Health (NIMH)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18
Max Age: N/A

Referral Letter Required

Yes

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

PET Imaging;
Epilepsy;
Inflammation;
Brain Imaging

Recruitment Keyword(s)

None

Condition(s)

Epilepsy;
Temporal Lobe

Investigational Drug(s)

[11C]DPA713

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Mental Health

Background:

- Some people with epilepsy have an epileptic focus, a small part of the brain that is the starting point of the seizure. This focus is like an irritant or an inflammation, and helps cause the seizure. People with epilepsy that affects the temporal lobe of the brain often have an epileptic focus. Researchers want to look at the epileptic focus by using a drug that attaches to a protein associated with inflammation. An imaging study with the drug will show how much inflammation is in the area of the brain where the seizures start. The drug, called [11C]DPA-713, will be tested for its effectiveness in people with temporal lobe epilepsy. Its effects will be compared with imaging studies given to healthy volunteers.

Objectives:

- To see if [11C]DPA-713 can show the inflammation in the epileptic focus of seizures.

Eligibility:

- Individuals at least 18 years of age who have temporal lobe epilepsy.

- Healthy volunteers at least 18 years of age.

Design:

- Participants will have three outpatient visits to the National Institutes of Health Clinical Center. The visits will last from 2 to 5 hours.

- Participants will be screened with a physical exam, neurological exam, and medical history. Blood samples will be collected before the start of the study.

- Participants will have a positron emission tomography (PET) scan. This scan will be used to look at brain chemistry and function. The study drug will be given during the scan to see how well it shows points of inflammation in the brain. Some participants will provide additional blood samples during the PET scan.

- Participants will also have a magnetic resonance imaging (MRI) scan. This scan will look at the structure of the brain.

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Eligibility

INCLUSION CRITERIA:

For healthy volunteers

- Age 18 or older.

- Able to give written informed consent.

- No prior diagnosis of drug or alcohol abuse or dependence.

For patients

-Age 18 or older.

- Able to give written informed consent.

- Having clinically documented partial seizures with consistent EEG evidence as defined by the 1981 International Classification of Epileptic Seizures, which may be refractory or responsive to standard antiepileptic treatment. This criterion will be established by preliminary screening in the NINDS Clinical Epilepsy Section outpatient clinic under protocol 01-N-0139, and if necessary, inpatient video-EEG monitoring. Seizure focus localization will be determined by standard clinical, neurophysiologic, and imaging studies.

- Negative toxicology testing at the time of screening.

- No prior diagnosis of drug or alcohol abuse or dependence.

EXCLUSION CRITERIA:

For healthy volunteers

- Any current Axis I diagnosis.

- Clinically significant laboratory abnormalities.

- Positive test for HIV.

- Unable to have a MRI scan.

- History of neurologic illness or injury with the potential to affect study data interpretation.

- History of seizures, other than in childhood and related to fever.

- Recent exposure to radiation (i.e., PET from other research) which when combined with this study would be above the allowable limits.

- Inability to lie flat on camera bed for at least two hours.

- Pregnancy or breast feeding.

- Able to get pregnant but does not use birth control.

- Drug/alcohol abuse or dependence

For patients

- Previous radiation exposure (X-rays, PET scans etc.) that, together with study procedures, would exceed NIH RSC research limits.

- Claustrophobia to a degree that the subject would feel uncomfortable in the MRI machine.

- History of brain disease other than epilepsy.

- Cannot lie on their back for at least two hours.

- Known cause for seizures, other than mesial temporal sclerosis, such as tumor or infection.

- Serious medical illness, other than epilepsy.

- Clinically significant laboratory abnormalities.

- Positive test for HIV.

- Brain abnormality such as a brain tumor, stroke, brain damage from head trauma or blood vessel abnormalities, on an MRI scan.

- Pregnancy or breast feeding.

- Able to get pregnant but does not use birth control.

- Risk for MRI scan, such as a pacemaker 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, or shrapnel fragments. Welders and metal workers are also at risk for injury because of possible small metal fragments in the eye of which they may be unaware.

-For drug-responsive subjects: occurrence of a seizure within the last three months.

-Drug/alcohol abuse or dependence


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Citations:

Boutin H, Chauveau F, Thominiaux C, Gregoire MC, James ML, Trebossen R, Hantraye P, Doll(SqrRoot) (Copyright) F, Tavitian B, Kassiou M. 11C-DPA-713: a novel peripheral benzodiazepine receptor PET ligand for in vivo imaging of neuroinflammation. J Nucl Med. 2007 Apr;48(4):573-81.

Banati RB, Newcombe J, Gunn RN, Cagnin A, Turkheimer F, Heppner F, Price G, Wegner F, Giovannoni G, Miller DH, Perkin GD, Smith T, Hewson AK, Bydder G, Kreutzberg GW, Jones T, Cuzner ML, Myers R. The peripheral benzodiazepine binding site in the brain in multiple sclerosis: quantitative in vivo imaging of microglia as a measure of disease activity. Brain. 2000 Nov;123 ( Pt 11):2321-37.

Banati RB, Myers R, Kreutzberg GW. PK ('peripheral benzodiazepine')--binding sites in the CNS indicate early and discrete brain lesions: microautoradiographic detection of [3H]PK11195 binding to activated microglia. J Neurocytol. 1997 Feb;26(2):77-82.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Robert B. Innis, M.D.
National Institute of Mental Health (NIMH)
BG 10 RM B1D43J
10 CENTER DR
BETHESDA MD 20814
(301) 594-1368
robert.innis@nih.gov

Patricia M. Reeves-Tyer, R. EEG T.
National Institute of Mental Health (NIMH)
National Institutes of Health
Building 10
Room 5S217
10 Center Drive
Bethesda, Maryland 20892
(301) 496-1923
tyerp@ninds.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:

NCT01793532

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