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

March 25, 2025 updated by: Ottawa Heart Institute Research Corporation

A Phase 1 Study of Safety, Tolerance, Pharmacokinetics and Nuclear Medicine Imaging of 123I-CMICE-013 Administered Intravenously in Healthy Adult Volunteers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1Y 4W7
        • University of Ottawa Heart Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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. All volunteers had a rest dose first followed by a stress dose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biodistribution of the 123I-CMICE-013 Within the Lungs
Time Frame: From enrollment to completion of imaging was 24 hours for each scan. Rest and stress scans were performed one week apart.
SPECT imaging was performed immediately following 123I-CMICE-013 injection, after 90 min, 4 hours, 6 hours and 24 hours. Region of interest was manually drawn on planar images. The total number of counts in the full body region of interest of the initial images was taken to correspond to 100% of the injected dose. The uptake in the organ as a percentage to injected dose was calculated.
From enrollment to completion of imaging was 24 hours for each scan. Rest and stress scans were performed one week apart.
Biodistribution of the 123I-CMICE-013 Within the Thyroid
Time Frame: From enrollment to completion of imaging was 24 hours for each scan. Rest and stress scans were performed one week apart.
SPECT imaging was performed immediately following 123I-CMICE-013 injection, after 90 min, 4 hours, 6 hours and 24 hours. Region of interest was manually drawn on planar images. The total number of counts in the full body region of interest of the initial images was taken to correspond to 100% of the injected dose. The uptake in the organ as a percentage to injected dose was calculated.
From enrollment to completion of imaging was 24 hours for each scan. Rest and stress scans were performed one week apart.
Biodistribution of the 123I-CMICE-013 Within the Heart Wall
Time Frame: From enrollment to completion of imaging was 24 hours for each scan. Rest and stress scans were performed one week apart.
SPECT imaging was performed at rest and at stress with each SPECT scan performed one week apart. SPECT imaging was performed immediately following 123I-CMICE-013 injection, after 90 min, 4 hours, 6 hours and 24 hours. Region of interest was manually drawn on planar images. The total number of counts in the full body region of interest of the initial images was taken to correspond to 100% of the injected dose. The uptake in the organ as a percentage to injected dose was calculated.
From enrollment to completion of imaging was 24 hours for each scan. Rest and stress scans were performed one week apart.
Biodistribution of the 123I-CMICE-013 Within the Bladder
Time Frame: From enrollment to completion of imaging was 24 hours for each scan. Rest and stress scans were performed one week apart.
SPECT imaging was performed immediately following 123I-CMICE-013 injection, after 90 min, 4 hours, 6 hours and 24 hours. Region of interest was manually drawn on planar images. The total number of counts in the full body region of interest of the initial images was taken to correspond to 100% of the injected dose. The uptake in the organ as a percentage to injected dose was calculated.
From enrollment to completion of imaging was 24 hours for each scan. Rest and stress scans were performed one week apart.
Biodistribution of the 123I-CMICE-013 Within the Liver
Time Frame: From enrollment to completion of imaging was 24 hours for each scan. Rest and stress scans were performed one week apart.
SPECT imaging was performed immediately following 123I-CMICE-013 injection, after 90 min, 4 hours, 6 hours and 24 hours. Region of interest was manually drawn on planar images. The total number of counts in the full body region of interest of the initial images was taken to correspond to 100% of the injected dose. The uptake in the organ as a percentage to injected dose was calculated.
From enrollment to completion of imaging was 24 hours for each scan. Rest and stress scans were performed one week apart.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Effective Dose of 123I-CMICE-013 for Men
Time Frame: From enrollment to completion of imaging was 24 hours for each scan. Rest and stress scans were performed one week apart.
The uptake of 123I-CMICE-013 in each organ from the primary outcomes were used to calculate the dose to each organ using the Olinda/EXM software package. doses for male patients were calculated using the adult male model. The results are reported as the mean and standard deviation of those measurements over all male participants for both the rest and stress SPECT imaging scans.
From enrollment to completion of imaging was 24 hours for each scan. Rest and stress scans were performed one week apart.
Total Effective Dose of 123I-CMICE-013 for Women
Time Frame: From enrollment to completion of imaging was 24 hours for each scan. Rest and stress scans were performed one week apart.
The uptake of 123I-CMICE-013 in each organ from the primary outcomes were used to calculate the dose to each organ using the Olinda/EXM software package. doses for male patients were calculated using the adult female model. The results are reported as the mean and standard deviation of those measurements over all female participants for both the rest and stress SPECT imaging scans.
From enrollment to completion of imaging was 24 hours for each scan. Rest and stress scans were performed one week apart.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ottawa Heart Institute Research Corporation

Collaborators

Canadian Institutes of Health Research (CIHR)

Investigators

  • Principal Investigator: Terrence D Ruddy, MD, Ottawa Heart Institute Research Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

March 7, 2012

First Submitted That Met QC Criteria

March 19, 2012

First Posted (Estimated)

March 20, 2012

Study Record Updates

Last Update Posted (Estimated)

March 26, 2025

Last Update Submitted That Met QC Criteria

March 25, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20120080-01H

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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