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

Technische Universität Dresden

Status and phase

Unknown

Phase 2

Conditions

Carotid Stenosis

Treatments

Radiation: EP 1645/Solution For Injection, 99mTC

Study type

Interventional

Funder types

Other

Identifiers

NCT00904254

TUD-Athero-040

2008-008443-14 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

21 estimated patients

Sex

All

Ages

50 to 80 years old

Volunteers

No Healthy Volunteers

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.