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Completed

NCT Number: NCT01558362

A Study of 123I-CMICE-013 Radiopharmaceutical in Healthy 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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

123I-CMICE-013

Drug

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Ottawa Heart Institute Research Corporation

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

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

Acronym: CMICE

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Mar 20, 2012
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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