A Study of 123I-CMICE-013 Radiopharmaceutical in Healthy Volunteers (CMICE)
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
123I-CMICE-013
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring myocardial perfusion imaging, single photon emission tomography, Coronary artery disease, gamma camera imaging, Phase 1 clinical trial, cyclotron
Eligibility Criteria
Inclusion Criteria:
- Age between 18 and 65 years
- No significant medical history
- Normal physical exam
- BMI ≤ 30 kg/m2
- No current use of prescription medication
- No clinically significant abnormalities in baseline laboratory work
- No clinically significant abnormalities in baseline 12 lead electrocardiogram
- Female subjects must be post-menopausal, surgically sterilized or have negative urine beta human chorionic gonadotropin pregnancy test at initial screening
Exclusion Criteria:
- Pregnancy
- Known hypersensitivity to the investigational drug or any of its components
- Claustrophobia or inability to lie still in a supine position
- Unwillingness to provide informed consent
Sites / Locations
- University of Ottawa Heart Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
123I-CMICE-013
Arm Description
Administration and analysis of alternative MPI radiotracer
Outcomes
Primary Outcome Measures
Biodistribution
Quantitative in vivo biodistribution will be determined through whole-body planar imaging immediately and at 90 mins, 4 hrs, 6 hrs and 24 hrs post injection. Venous blood samples of 10 ml volume each will be taken at nominal times of 5, 10, 15, 30, 60, 90 and 180 minutes post administration and at 6 and 24 hours and activity measured. Urine and faeces as voided up to 24 hrs post administration will be assayed.
Internal radiation dose, Effective Dose Equivalent (ICRP 30), Effective Dose (ICRP 60) and organ residence times will be calculated.
Secondary Outcome Measures
Safety/Tolerability
Adverse events and Serious Adverse Events will be recorded and reported.
Full Information
NCT ID
NCT01558362
First Posted
March 7, 2012
Last Updated
April 21, 2017
Sponsor
Ottawa Heart Institute Research Corporation
Collaborators
Canadian Institutes of Health Research (CIHR)
1. Study Identification
Unique Protocol Identification Number
NCT01558362
Brief Title
A Study of 123I-CMICE-013 Radiopharmaceutical in Healthy Volunteers
Acronym
CMICE
Official Title
A Phase 1 Study of Safety, Tolerance, Pharmacokinetics and Nuclear Medicine Imaging of 123I-CMICE-013 Administered Intravenously in Healthy Adult Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ottawa Heart Institute Research Corporation
Collaborators
Canadian Institutes of Health Research (CIHR)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The need exists for alternatives to 99mTc based perfusion radiotracers for cardiac patient management. An alternative radiotracer, I123-CMICE-013, has been developed at the Canadian Molecular Imaging Center of Excellence (C-MICE) at the University of Ottawa Heart Institute. Initial testing results in rats and pigs suggest that in addition to being a cyclotron-produced alternative to 99mTc tracers, I-123-CMICE-013 may be a superior tracer for measuring myocardial perfusion.This Phase 1 study will study the safety and tolerability, biodistribution, pharmacokinetics and radiation dosimetry, and distribution and localization of I123-CMICE-013in healthy adult volunteers.
Detailed Description
Single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI) is an established, cost effective tool for the risk stratification and management of patients suspected or known to have coronary artery disease (CAD)Myocardial perfusion imaging is significantly affected by interruptions in the supply of 99mMo, the parent isotope of 99mTc used for the majority of MPI. An alternative radiotracer, I123-CMICE-013,developed at the Canadian Molecular Imaging Center of Excellence (C-MICE) at the University of Ottawa Heart Institute, has completed pre-clinical trial testing and is ready for Phase 1 human trials.
This Phase I study will be a single centre, open label study. Subjects will receive 2 doses of study drug. One rest dose and one stress dose will be administered on separate days, one week apart. Subjects will undergo a standard clinical exercise stress protocol for the stress dose. Gamma camera imaging following each administration will be done over 2 days.
Biodistribution, pharmacokinetics, dosimetry and safety variables will be analyzed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
myocardial perfusion imaging, single photon emission tomography, Coronary artery disease, gamma camera imaging, Phase 1 clinical trial, cyclotron
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
123I-CMICE-013
Arm Type
Experimental
Arm Description
Administration and analysis of alternative MPI radiotracer
Intervention Type
Drug
Intervention Name(s)
123I-CMICE-013
Intervention Description
2 intravenous doses of drug will be given one week apart. Doses will be equivalent to 1 rest dose and 1 stress dose. Serial nuclear imaging will follow dose injections.
Primary Outcome Measure Information:
Title
Biodistribution
Description
Quantitative in vivo biodistribution will be determined through whole-body planar imaging immediately and at 90 mins, 4 hrs, 6 hrs and 24 hrs post injection. Venous blood samples of 10 ml volume each will be taken at nominal times of 5, 10, 15, 30, 60, 90 and 180 minutes post administration and at 6 and 24 hours and activity measured. Urine and faeces as voided up to 24 hrs post administration will be assayed.
Internal radiation dose, Effective Dose Equivalent (ICRP 30), Effective Dose (ICRP 60) and organ residence times will be calculated.
Time Frame
0 to 24 hours post injection
Secondary Outcome Measure Information:
Title
Safety/Tolerability
Description
Adverse events and Serious Adverse Events will be recorded and reported.
Time Frame
0 to 7 days post injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age between 18 and 65 years
No significant medical history
Normal physical exam
BMI ≤ 30 kg/m2
No current use of prescription medication
No clinically significant abnormalities in baseline laboratory work
No clinically significant abnormalities in baseline 12 lead electrocardiogram
Female subjects must be post-menopausal, surgically sterilized or have negative urine beta human chorionic gonadotropin pregnancy test at initial screening
Exclusion Criteria:
Pregnancy
Known hypersensitivity to the investigational drug or any of its components
Claustrophobia or inability to lie still in a supine position
Unwillingness to provide informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terrence D Ruddy, MD
Organizational Affiliation
Ottawa Heart Institute Research Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Ottawa Heart Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4W7
Country
Canada
12. IPD Sharing Statement
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A Study of 123I-CMICE-013 Radiopharmaceutical in Healthy Volunteers
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