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

Primary Purpose

Carotid Stenosis

Status

Unknown status

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

EP 1645/Solution For Injection, 99mTC

About this trial

This is an interventional diagnostic trial for Carotid Stenosis focused on measuring 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

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1, diagnostic comparison

Arm Description

EP 1645/Solution For Injection

Outcomes

Primary Outcome Measures

Scintigraphic confirmation of clinical disease

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.

Secondary Outcome Measures

Adverse events (signs and symptoms), laboratory tests.

Full Information

NCT ID

NCT00904254

First Posted

May 18, 2009

Last Updated

February 2, 2012

Sponsor

Technische Universität Dresden

Collaborators

Klinikum Chemnitz gGmbH

1. Study Identification

Unique Protocol Identification Number

NCT00904254

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

February 2012

Overall Recruitment Status

Unknown status

Study Start Date

January 2015 (undefined)

Primary Completion Date

January 2016 (Anticipated)

Study Completion Date

January 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Technische Universität Dresden

Collaborators

Klinikum Chemnitz gGmbH

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carotid Stenosis

Keywords

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

21 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

1, diagnostic comparison

Arm Type

Experimental

Arm Description

EP 1645/Solution For Injection

Intervention Type

Radiation

Intervention Name(s)

EP 1645/Solution For Injection, 99mTC

Other Intervention Name(s)

CD4 Antibody

Intervention Description

(Fab-fragment of Anti-human CD4,technetium-99m)

Primary Outcome Measure Information:

Title

Scintigraphic confirmation of clinical disease

Description

Time Frame

A total of 16 patients will be recruited for this study.

Secondary Outcome Measure Information:

Title

Adverse events (signs and symptoms), laboratory tests.

Time Frame

during the entire study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Joachim Siegert, MD, PhD

Phone

+49 351 458 5694

joachim.siegert@mailbox.tu-dresden.de

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christoph Schindler Schindler, MD

Organizational Affiliation

Institute of Clinical Pharmacology, Medical Faculty, Technical University Dresden

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

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

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