Assessment of [11C]ER176 to Image Translocator Protein in Brain and Whole Body of Healthy People

NCT02147392 | Completed Early Phase 1

• 2 other identifiers: 14011714-M-0117
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Background: \- A protein called translocator protein may play a role in brain inflammation. Sometimes it is present at higher levels in the lungs than in the brain. Researchers want to see if a drug called \[11C\]ER176 can provide an image of this protein in the brain. Objective: \- To test the ability of a drug to image a protein, and test how it is distributed in the body. Eligibility: \- Healthy adults over age 18. Design:

• Participants will be screened with medical history, physical exam, and blood and urine tests.
• Participants will have a PET scan of the brain using \[11C\]ER176. It will be injected through an intravenous tube into 1-2 arm veins. A tube may also be put into an artery at the wrist or elbow. Some participants will also have a lung scan.
• For the PET, participants will lie on a bed that slides in and out of a doughnut-shaped scanner. A plastic mask will be molded to their face and head. They may be wrapped with restraining sheets. The scan will last about 120 minutes. Blood may be taken during the scan.
• Blood and urine will be taken before and after the scan.
• During another visit, participants will have an MRI scan of the brain. Participants will lie on a table that slides in and out of a metal cylinder. A strong magnetic field and radio waves will take pictures of the brain. The scanner makes loud knocking noises. Participants will be given earplugs.
• Some participants will have only a whole-body PET scan using \[11C\]ER176.

Conditions

Pharmacokinetics; Adult

Keywords

PET Imaging

Outcome Measures

Primary Outcomes (1)

• The identifiability and time stability of distribution volume calculated with compartmental modeling and evaluate the genotype sensitivity of [11C]ER-176

  1 year

Secondary Outcomes (1)

• Whole-body biodistribution and dosimetry of [11C]ER-176.

  1 year

Interventions

[11C]ER-176 DRUG

Eligibility Criteria

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

You may qualify if:

• Age 18 or older.
• Able to give written informed consent.
• Healthy based on medical history, physical examination and laboratory testing.

You may not qualify if:

• 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.
• Drug/alcohol abuse or dependence
• Current use of prescription or chronic (more than 3 continuous weeks) use of over-the-counter medications for pain, fever or other inflammation including prednisolone (Orapred), aspirin (Ecotrin), ibuprofen (Advil), and acetaminophen (Tylenol). The medications will be reviewed to see if subject can be in the study. If the subject is taking any medication that is not permitted, he/she may be in the study if the medication can be safely stopped for three weeks. The subject s primary care doctor will be contacted to stop a medication if necessary. A written permission will be obtained from the subject to contact his/her doctor.

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 (4)

• 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

• 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

• Cagnin A, Brooks DJ, Kennedy AM, Gunn RN, Myers R, Turkheimer FE, Jones T, Banati RB. In-vivo measurement of activated microglia in dementia. Lancet. 2001 Aug 11;358(9280):461-7. doi: 10.1016/S0140-6736(01)05625-2.

  PMID: 11513911 BACKGROUND

• Kobayashi M, Jiang T, Telu S, Zoghbi SS, Gunn RN, Rabiner EA, Owen DR, Guo Q, Pike VW, Innis RB, Fujita M. 11C-DPA-713 has much greater specific binding to translocator protein 18 kDa (TSPO) in human brain than 11C-( R)-PK11195. J Cereb Blood Flow Metab. 2018 Mar;38(3):393-403. doi: 10.1177/0271678X17699223. Epub 2017 Mar 21.

  PMID: 28322082 DERIVED

Study Officials

• Robert B Innis, M.D.

  National Institute of Mental Health (NIMH)

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 22, 2014
• First Posted: May 26, 2014
• Study Start: May 14, 2014
• Primary Completion: June 16, 2016
• Study Completion: June 16, 2016
• Last Updated: July 5, 2018

Record last verified: 2017-01-26

Locations

US (1)