The Use of Anti-CD4 mAb-Fragment for Imaging of Local Inflammation in Patients With Carotid Artery Stenosis
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Carotid Stenosis |
Radiation: EP 1645/Solution For Injection, 99mTC |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study 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. ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 21 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 50 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- male and female with either symptomatic (> 60%) or asymptomatic (> 80%) carotid artery stenosis between 50 and 80 years of age
- Symptomatic stenosis of the A. carotis interna is defined as occurence of focal ischemic symptoms in the area of the supplying vessel, occurence of a transischemic attack (TIA), occurence of focal neurologic dysfunction or unilateral blindness.
- informed consent in accordance with ICH GCP and § 40 AMG and StrahlSchV
- sonography status from the patient is present (printout is available)
- patients available for carotid surgery within 3 months after diagnosis of carotid artery stenosis
- In patients with bilateral disease, only the stenosis considered for surgery will be included in the endpoint evaluation.
Exclusion Criteria:
- patients > 80 years
- major disease of the cardiovascular system, respiratory system, hepatobiliary system or CNS, which prevents patients from the study participation as to the opinion of the investigator
- hepatic (transaminases > 3 x norm) or renal (serum creatinine increase > 2x norm) insufficiency
- regular drug intake of biologics. Intake of all other drugs must be judged by investigator and must be the strictly documented
- previous administration of xenogenous proteins
- history of anaphylactic reaction to any drug administered by a parenteral pathway
- previous participation in a radiopharmaceutical drug trial (unless the effective dose acquired by participation in the current trial will remain below 10 mSv)
- participation in any clinical drug trial within 3 months prior to enrolment
- women of child-bearing potential (child-bearing potential to be ruled out by one of the following: at least 2 years past menopause, hysterectomy, bilateral oophorectomy, bilateral tubal ligation)
- Patients presenting clinical signs of severe systemic infection (CRP > 50 mg/dl)
- Carotid Surgery (TEA) not possible within a time frame of 7 days after imaging
- Patients with bilateral carotid stenosis if clinically regarded as critical by the angiologists.
Contacts and Locations| Contact: Joachim Siegert, MD, PhD | +49 351 458 5694 | joachim.siegert@mailbox.tu-dresden.de |
| Principal Investigator: | Christoph Schindler Schindler, MD | Institute of Clinical Pharmacology, Medical Faculty, Technical University Dresden |
More Information
No publications provided
| Responsible Party: | Dresden University of Technology |
| ClinicalTrials.gov Identifier: | NCT00904254 History of Changes |
| Other Study ID Numbers: | TUD-Athero-040, 2008-008443-14 |
| Study First Received: | May 18, 2009 |
| Last Updated: | February 2, 2012 |
| Health Authority: | Germany: Paul-Ehrlich-Institut |
Keywords provided by Dresden University of Technology:
|
cerebrovascular disorders symptomatic carotid artery stenosis asymptomatic carotid artery stenosis monoclonal antibody diagnostics molecular target |
immunoglobulin Fab fragments physiological effects of drugs Tc99m-pertechnetate Fab-fragment of Anti-human CD4 Antibodies, Monoclonal Antibodies |
Additional relevant MeSH terms:
|
Carotid Stenosis Constriction, Pathologic Inflammation Carotid Artery Diseases Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Arterial Occlusive Diseases |
Vascular Diseases Cardiovascular Diseases Pathological Conditions, Anatomical Pathologic Processes Antibodies Immunoglobulin Fab Fragments Physiological Effects of Drugs Immunologic Factors Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013