PET Brain and Whole Body Distribution Studies for Nociceptin/Orphanin FQ Peptide (NOP) Receptor Using [11C]NOP-1A
|ClinicalTrials.gov Identifier: NCT01198197|
Recruitment Status : Completed
First Posted : September 9, 2010
Last Update Posted : May 1, 2018
|First Submitted Date ICMJE||September 8, 2010|
|First Posted Date ICMJE||September 9, 2010|
|Last Update Posted Date||May 1, 2018|
|Study Start Date ICMJE||September 3, 2010|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||For the PET scans, we will measure the regional densities of NOP receptors as distribution volume (VT). Distribution volume is the ratio at equilibrium of brain uptake to the concentration of parent radioligand in plasma. [ Time Frame: 2 years ]|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT01198197 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||PET Brain and Whole Body Distribution Studies for Nociceptin/Orphanin FQ Peptide (NOP) Receptor Using [11C]NOP-1A|
|Official Title ICMJE||PET Brain and Whole Body Distribution Studies for Nociceptin/Orphanin FQ Peptide (NOP) Receptor Using [(11)C]NOP-1A|
- A small brain protein called nociceptin/orphanin FQ peptide (NOP) receptor may be involved in several brain diseases such as anxiety, depression, drug abuse, and seizures. Researchers are interested in testing a new radioactive chemical that will help locate NOP receptors in the brain during imaging studies such as positron emission tomography (PET) scans. Because this chemical has not yet been approved by the Food and Drug Administration, it is considered to be an experimental drug.
- To investigate the effectiveness of the experimental chemical [11C]NOP-1A in imaging studies of the nociceptin/orphanin FQ peptide (NOP) receptor.
- Healthy volunteers between 18 and 50 years of age who are able to have imaging studies.
Nociceptin/orphanin FQ peptide (NOP) receptor is a new class of opioid receptor cloned in 1994 before identifying the endogenous ligand. Within a year, endogenous ligand was identified and soon many ligands were developed and evaluated in vitro and in vivo for NOP receptor distribution and activity. NOP receptor is widely distributed in brain, spinal cord and in peripheral organs such as heart, lungs, kidney, intestine and liver. Being a G-protein coupled receptor, its activation leads to changes in intracellular signal transduction mediated by adenylyl cyclase, Ca(2+) and K(+) ion channels, mitogen-activated kinase and phospholipase C. Based on preclinical studies, NOP receptor is implicated in regulation of pain, anxiety and depression, drug abuse, feeding, learning/memory, and motor activity.
Since the time of cloning the receptor and identification of endogenous ligand, numerous compounds have been designed targeting this receptor. However, there are no PET radioligands currently available to study NOP distribution and activity in humans. We wish to test a newly developed PET radioligand, [(11)C]NOP-1A to study the role of NOP receptors in humans.
The purpose of this protocol is (1) to perform brain imaging using [(11)C]NOP-1A in healthy volunteers to characterize the brain uptake and distribution (2) to perform whole body PET studies in healthy volunteers in order to estimate radiation absorbed doses for [(11)C]NOP-1A, (3) to perform brain test-retest studies in healthy volunteers in order to further examine the precision of the measurement of receptor binding and to determine optimal parameters for future experiments using [(11)C]NOP-1A, and, (4) to compare [(11)C]NOP-1A concentrations in artery and vein of healthy volunteers to assess the feasibility of replacing the arterial line with a less invasive venous line for brain scans.
Successful development of a PET radioligand to image NOP receptor will have a strong impact on further understanding and clinical management of neuropsychiatric disorders that are mediated by opioid receptor system. Future experiments will include studies on any relevant neuropsychiatric disorder.
|Study Type ICMJE||Interventional|
|Study Phase||Early Phase 1|
|Study Design ICMJE||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
|Intervention ICMJE||Drug: NOP-1A|
|Study Arms||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Actual Enrollment ICMJE
|Original Estimated Enrollment ICMJE
|Actual Study Completion Date||February 28, 2014|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Subjects must be adults between 18-50 years old.
Subjects must be able and willing to give written informed consent.
Current psychiatric illness or severe systemic disease based on history and physical exam.
If women, pregnancy or breast feeding (betaHCG will be measured in all female patients within 24 hours of scan and must be negative)
Clinically significant laboratory abnormalities.
Serious medical problems including but not limited to chronic neurological disease such as multiple sclerosis, autoimmune diseases or any cardiopulmonary disease.
Head trauma resulting in a period of unconsciousness lasting longer than 10 minutes.
Recent exposure to radiation (i.e., PET from other research) which when combined with this study would be above the allowable limits.
Positive urine drug screen at screening.
Inability to lie flat on camera bed for about 2.5 hours
Subjects who have metallic foreign bodies that would be affected by the MRI magnet, or fear of enclosed spaces likely to make the subject unable to undergo an MRI scan.
|Ages||18 Years to 50 Years (Adult)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT01198197|
|Other Study ID Numbers ICMJE||100204
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institute of Mental Health (NIMH)|
|Collaborators ICMJE||Not Provided|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||September 5, 2014|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP