Phase 1
N=12
A Study of 123I-CMICE-013 Radiopharmaceutical in Healthy Volunteers
Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT01558362 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Biodistribution of the 123I-CMICE-013 Within the Lungs — 8.4; 7.1; 7.1; 6.2 percentage of total injected dose
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- 123I-CMICE-013 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ottawa Heart Institute Research Corporation
- Primary completion
- Sep 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Biodistribution of the 123I-CMICE-013 Within the Lungs |
8.4; 7.1; 7.1; 6.2; 5.3; 4.8 | — |
| PRIMARY Biodistribution of the 123I-CMICE-013 Within the Thyroid |
0.8; 0.5; 0.7; 0.5; 0.6; 0.4 | — |
| PRIMARY Biodistribution of the 123I-CMICE-013 Within the Heart Wall |
5.0; 3.2; 4.0; 2.6; 2.7; 2.0 | — |
| PRIMARY Biodistribution of the 123I-CMICE-013 Within the Bladder |
3.6; 2.3; 5.3; 4.7; 6.9; 4.8 | — |
| PRIMARY Biodistribution of the 123I-CMICE-013 Within the Liver |
14.4; 9.0; 8.4; 5.9; 5.4; 4.3 | — |
| SECONDARY Total Effective Dose of 123I-CMICE-013 for Men |
24.0; 23.0 | — |
| SECONDARY Total Effective Dose of 123I-CMICE-013 for Women |
30.0; 29.0 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01558362). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.