Study of [11C]DPA-713 for Temporal Lobe Epilepsy

NCT01793532 | Completed

• 2 other identifiers: 13007013-M-0070
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Epilepsy; Temporal Lobe

Keywords

PET Imaging; Epilepsy; Inflammation; Brain Imaging

Outcome Measures

Primary Outcomes (1)

• Brain uptake of radioligand

  90 minutes

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

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)

• Boutin H, Chauveau F, Thominiaux C, Gregoire MC, James ML, Trebossen R, Hantraye P, Dolle 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. doi: 10.2967/jnumed.106.036764.

  PMID: 17401094 BACKGROUND

• 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. doi: 10.1093/brain/123.11.2321.

  PMID: 11050032 BACKGROUND

• 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. doi: 10.1023/a:1018567510105.

  PMID: 9181482 BACKGROUND

MeSH Terms

Conditions

Epilepsy; Inflammation

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Robert B Innis, M.D.

  National Institute of Mental Health (NIMH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2013
• First Posted: February 15, 2013
• Study Start: January 31, 2013
• Primary Completion: June 8, 2016
• Study Completion: June 8, 2016
• Last Updated: December 16, 2019

Record last verified: 2016-07-28

Locations

US (1)