The Use of Anti-CD4 mAb-Fragment for Imaging of Local Inflammation in Patients With Carotid Artery Stenosis
Recruitment status was: Not yet recruiting
|Carotid Stenosis||Radiation: EP 1645/Solution For Injection, 99mTC||Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|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.|
- 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.
- Adverse events (signs and symptoms), laboratory tests. [ Time Frame: during the entire study ]
|Study Start Date:||January 2015|
|Estimated Study Completion Date:||January 2016|
|Estimated Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
Experimental: 1, diagnostic comparison
EP 1645/Solution For Injection
Radiation: EP 1645/Solution For Injection, 99mTC
(Fab-fragment of Anti-human CD4,technetium-99m)
Other Name: CD4 Antibody
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00904254
|Contact: Joachim Siegert, MD, PhD||+49 351 458 email@example.com|
|Principal Investigator:||Christoph Schindler Schindler, MD||Institute of Clinical Pharmacology, Medical Faculty, Technical University Dresden|