Clinical Trial: The Use of Anti-CD4 mAb-Fragment for Imaging of Local Inflammation in Patients With Carotid Artery Stenosis

Study Status: Terminated
Recruit Status: Unknown status
Study Type: Interventional

Official Title: The Use of Anti-CD4 mAb-Fragment for Imaging of Local Inflammation in Patients With Asymptomatic and Symptomatic Carotid Artery Stenosis - an Open Proof of Concept Study.

Brief Summary: The primary objective of this study is to proof the concept of EP 1645 as a diagnostic tool for carotid artery atherosclerosis and plaque instability and to assess the safety and tolerability of this diagnostic agent, a monoclonal antibody fragment (Fab') conjugated with the diagnostic radionuclide 99mTc. Safety and tolerability will be determined by adverse events (AEs) observed and reported upon administration of the product and the absorbed dose of radiation.

Detailed Summary:

For the evaluation of atherosclerosis in carotid arteries up to now sonographic measurements of plaque burden are used. This method has advantages for investigation of carotid arteries since this region is easy accessible for this investigation. However, it does not allow evaluation of the vessels which are remote from the body surface, as, for instance, coronary arteries. A method for non-invasive reliable evaluation of such arteries is needed. Also the distinction between vulnerable and stable plaque has a great clinical relevance. A quantifiable method for the determination of the effects of new therapeutic approaches would be highly appreciated.

It is expected, that the new antibody fragment with its radioactive linkage will allow displaying an image of the activity distribution of the disease. Due to the fact that only patients with atherosclerotic changes in carotid arteries allow comparing the activity and the clinical signs of disease, this proof of concept study (phase II study) will be performed in patients with asymptomatic and symptomatic carotid artery stenosis.


Sponsor: Technische Universität Dresden

Current Primary Outcome: Scintigraphic confirmation of clinical disease [ Time Frame: A total of 16 patients will be recruited for this study. ]

8 patients with stable atherosclerosis will be assigned to study group 1 and 8 patients with instable atherosclerosis will be assigned to study group 2. It is expected that the study substance enriches only in carotid arteries of patients assigned to study group 2 and not in lesions of patients assigned to group 1. The study results of this proof-of-concept-study will be compared purely with descriptive methods in order to create a consistent set data which can be used for a valid case number estimation for a future phase II trial.


Original Primary Outcome:

Current Secondary Outcome: Adverse events (signs and symptoms), laboratory tests. [ Time Frame: during the entire study ]

Original Secondary Outcome:

Information By: Technische Universität Dresden

Dates:
Date Received: May 18, 2009
Date Started: January 2015
Date Completion: January 2016
Last Updated: February 2, 2012
Last Verified: February 2012