Healthy Clinical Trial
Official title:
PET Imaging of Peripheral Benzodiazepine Receptors in Patients With Carotid Atherosclerosis
Inflammation in the vascular wall is important in atherosclerosis and the blockage of the artery. The peripheral benzodiazepine receptor is involved in inflammation and in this protocol we will attempt to take pictures, using PET camera, of inflammation in patients with atherosclerosis and compare those of healthy people.
Objective
Inflammation in the vascular wall plays an important role in the pathophysiology of
atherosclerosis, including development of plaque, plaque destabilization and rupture.
Clinical and basic scientific data demonstrate the importance of peripheral white blood
cells in this process. Therefore, a noninvasive method to detect inflammatory activity in
atherosclerosis may be of great value to help determine prognosis, direct therapy and
perhaps assess novel therapies for stabilization of atherosclerotic plaque.
The peripheral benzodiazepine receptor (PBR) is distinct from central benzodiazepine
receptors associated with GABAA receptors and has been associated with immune function. PBR
is expressed in macrophages, therefore, they may be a clinically useful marker to detect
inflammation. Our preliminary autoradiographic data demonstrate specific PBR binding in
carotid atherosclerosis samples. Though PBR has been imaged in vivo with positron emission
tomography (PET) using [(11)C]1-(2-chlorophenyl-N-methylpropyl)-3-isoquinoline carboxamide
(PK11195), we developed a new ligand,
[(11)C]N-acetyl-N-(2-methoxybenzyl)-2-phenoxy-5-pyridinamine (PBR28) that shows greater
specific signal than [(11)C]PK11195 in non-human primates.
The objective of this protocol is to assess the utility of [(11)C]PBR28 PET to detect
inflammation in unstable atherosclerosis plaques and large vessels with inflammation.
Study population
Twenty patients with carotid atherosclerosis, 20 patients with large vessel vasculitis
including Takayasu's and Giant Cell arteritis, and 20 age-matched healthy subjects will have
one PET scan.
Design
A [(11)C]PBR28 PET scan and a [18 F] fluorodeoxyglucose (FDG) PET scan will be performed in
patients with carotid atherosclerosis. If the patient has endarterectomy after the PET scan,
endarterectomy samples will be evaluated by in vitro autoradiography using [3H]PK 11195 and
immunohistological staining with macrophage markers. Patients with large vessel vasculitis
and healthy subjects will also have a [(11)C]PBR28 PET scan [18 F]FDG PET scan.
Outcome measures
Binding of [(11)C]PBR28 in atherosclerotic lesions, aortic arch and its branches will be
compared with the binding in the contralateral carotid artery and those in healthy subjects.
Binding of [(11)C]PBR28 will also be compared with accumulation of [18 F]FDG in each region.
In addition, if the patients with atherosclerosis have endarterectomy, the binding in the
atherosclerotic lesions will be compared with immunohistological staining of macrophage
markers.
;
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06052553 -
A Study of TopSpin360 Training Device
|
N/A | |
| Completed |
NCT05511077 -
Biomarkers of Oat Product Intake: The BiOAT Marker Study
|
N/A | |
| Recruiting |
NCT04632485 -
Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
|
||
| Completed |
NCT05931237 -
Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults
|
N/A | |
| Completed |
NCT04527718 -
Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers
|
Phase 1 | |
| Terminated |
NCT04556032 -
Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women
|
N/A | |
| Completed |
NCT04065295 -
A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225
|
Phase 1 | |
| Completed |
NCT04998695 -
Health Effects of Consuming Olive Pomace Oil
|
N/A | |
| Completed |
NCT04107441 -
AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT01442831 -
Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects
|
Phase 1 | |
| Terminated |
NCT05934942 -
A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood
|
Phase 1 | |
| Recruiting |
NCT05525845 -
Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI
|
N/A | |
| Completed |
NCT05515328 -
A Study in Healthy Men to Test How BI 685509 is Processed in the Body
|
Phase 1 | |
| Completed |
NCT05030857 -
Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT04967157 -
Cognitive Effects of Citicoline on Attention in Healthy Men and Women
|
N/A | |
| Recruiting |
NCT04714294 -
Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers
|
Phase 1 | |
| Recruiting |
NCT04494269 -
A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls
|
Phase 1 | |
| Completed |
NCT04539756 -
Writing Activities and Emotions
|
N/A | |
| Recruiting |
NCT04098510 -
Concentration of MitoQ in Human Skeletal Muscle
|
N/A | |
| Completed |
NCT03308110 -
Bioavailability and Food Effect Study of Two Formulations of PF-06650833
|
Phase 1 |