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A Study of 123I-CMICE-013 Radiopharmaceutical in Healthy Volunteers (CMICE)

This study has been completed.
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Terrence Ruddy, Ottawa Heart Institute Research Corporation Identifier:
First received: March 7, 2012
Last updated: April 21, 2017
Last verified: April 2017
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.

Condition Intervention Phase
Coronary Artery Disease Drug: 123I-CMICE-013 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Phase 1 Study of Safety, Tolerance, Pharmacokinetics and Nuclear Medicine Imaging of 123I-CMICE-013 Administered Intravenously in Healthy Adult Volunteers

Further study details as provided by Terrence Ruddy, Ottawa Heart Institute Research Corporation:

Primary Outcome Measures:
  • Biodistribution [ Time Frame: 0 to 24 hours post injection ]

    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 [ Time Frame: 0 to 7 days post injection ]
    Adverse events and Serious Adverse Events will be recorded and reported.

Enrollment: 12
Study Start Date: April 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 123I-CMICE-013
Administration and analysis of alternative MPI radiotracer
Drug: 123I-CMICE-013
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.

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.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Age between 18 and 65 years
  2. No significant medical history
  3. Normal physical exam
  4. BMI ≤ 30 kg/m2
  5. No current use of prescription medication
  6. No clinically significant abnormalities in baseline laboratory work
  7. No clinically significant abnormalities in baseline 12 lead electrocardiogram
  8. Female subjects must be post-menopausal, surgically sterilized or have negative urine beta human chorionic gonadotropin pregnancy test at initial screening

Exclusion Criteria:

  1. Pregnancy
  2. Known hypersensitivity to the investigational drug or any of its components
  3. Claustrophobia or inability to lie still in a supine position
  4. Unwillingness to provide informed consent
  Contacts and Locations
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Please refer to this study by its identifier: NCT01558362

Canada, Ontario
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
Canadian Institutes of Health Research (CIHR)
Principal Investigator: Terrence D Ruddy, MD Ottawa Heart Institute Research Corporation
  More Information

Responsible Party: Terrence Ruddy, Principal Investigator, Ottawa Heart Institute Research Corporation Identifier: NCT01558362     History of Changes
Other Study ID Numbers: 20120080-01H
Study First Received: March 7, 2012
Last Updated: April 21, 2017

Keywords provided by Terrence Ruddy, Ottawa Heart Institute Research Corporation:
myocardial perfusion imaging
single photon emission tomography
Coronary artery disease
gamma camera imaging
Phase 1 clinical trial

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Molecular Mechanisms of Pharmacological Action processed this record on August 23, 2017