The Use of Anti-CD4 mAb-Fragment for Imaging of Local Inflammation in Patients With Carotid Arter… (NCT00904254) | Clinical Trial Compass
UnknownPhase 2
The Use of Anti-CD4 mAb-Fragment for Imaging of Local Inflammation in Patients With Carotid Artery Stenosis
21 participantsStarted 2015-01
Plain-language 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.
Who can participate
Age range50 Years – 80 Years
SexALL
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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 wil…
What they're measuring
1
Scintigraphic confirmation of clinical disease
Timeframe: A total of 16 patients will be recruited for this study.