Coronary Artery DiseasePhase 1CMICENCT01558362

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

A Phase 1 study testing 123I-CMICE-013 in people with Coronary Artery Disease, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Coronary Artery Disease
What is being tested?: 123I-CMICE-013
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteCanada
Study dates: Apr 2012to Sep 2012
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site

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

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Conditions: Coronary Artery Disease
Being tested: 123I-CMICE-013
Keywords: myocardial perfusion imaging, single photon emission tomography, Coronary artery disease, gamma camera imaging, Phase 1 clinical trial, cyclotron
Medical subject headings: Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

123I-CMICE-013Drug
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.

Study groups in NCT01558362
Study group	Role	What they receive
123I-CMICE-013	Experimental	Administration and analysis of alternative MPI radiotracer Receives: Drug: 123I-CMICE-013

What is being measured

The primary outcome is the main question the study is designed to answer.

Biodistribution of the 123I-CMICE-013 Within the Lungs
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: From enrollment to completion of imaging was 24 hours for each scan. Rest and stress scans were performed one week apart.

Secondary outcomes (2)

Total Effective Dose of 123I-CMICE-013 for Men
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.
Measured: 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
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.
Measured: From enrollment to completion of imaging was 24 hours for each scan. Rest and stress scans were performed one week apart.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2012Sep 2012

First posted20 Mar 2012 (estimated)
Study startApr 2012
Primary completionSep 2012
Study completionSep 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
More trials run by Ottawa Heart Institute Research CorporationThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01558362
Sponsor's protocol ID: 20120080-01H
Acronym: CMICE
Status last verified: Jan 2025
First submitted: 7 Mar 2012
Last updated: 26 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Study of Safety, Tolerance, Pharmacokinetics and Nuclear Medicine Imaging of 123I-CMICE-013 Administered Intravenously in Healthy Adult Volunteers
ClinicalTrials.gov ID: NCT01558362
Acronym / sponsor ID: CMICE / 20120080-01H
Conditions: Coronary Artery Disease
Keywords: myocardial perfusion imaging, single photon emission tomography, Coronary artery disease, gamma camera imaging, Phase 1 clinical trial, cyclotron
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Ottawa Heart Institute Research CorporationUniversity, hospital or other
Collaborators: Canadian Institutes of Health Research (CIHR)
Study start: Apr 2012
Primary completion: Sep 2012 (actual)
Study completion: Sep 2012 (actual)
First posted: 20 Mar 2012 (estimated)
Results: Posted 26 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Biodistribution, pharmacokinetics, dosimetry and safety variables will be analyzed.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
123I-CMICE-013	Experimental	Drug: 123I-CMICE-013Administration and analysis of alternative MPI radiotracer

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Age between 18 and 65 years
No significant medical history
Normal physical exam
BMI ≤ 30 kg/m2
No current use of prescription medication

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
123I-CMICE-0132 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.	Drug	123I-CMICE-013

Primary outcome

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.
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.
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.
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.
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.

2 secondary outcomes

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.
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.

Results and safety

Results posted to the registry on 26 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
123I-CMICE-013	12	12

Primary outcome: 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.. Mean (Standard Deviation). Unit: percentage of total injected dose

Measure	Lung Biodistribution of 123I-CMICE-013 Post Rest Imaging n = 12	Lung Biodistribution of 123I-CMICE-013 Post Stress Imaging n = 12
Biodistribution immediately after 123I-CMICE-013 injection.	8.4 (1.9)	7.1 (1.1)
Biodistribution at 90 min post 123I-CMICE-013 injection	7.1 (1.8)	6.2 (1.0)
Biodistribution at 4 hours post 123I-CMICE-013 injection	5.3 (1.4)	4.8 (0.9)
Biodistribution at 6 hours post 123I-CMICE-013 injection	4.3 (1.1)	4.1 (0.8)
Biodistribution at 24 hours post 123I-CMICE-013 injection	0.8 (0.2)	1.0 (0.2)

Population analysed: Normal, healthy volunteers, with no pre-existing medical conditions were recruited. The volunteers were six (6) males and six (6) females and ranged from 18 to 42 years of age.

Primary outcome: Biodistribution of the 123I-CMICE-013 Within the Thyroid

Measure	Thyroid Biodistribution of 123I-CMICE-013 Post Rest Imaging n = 12	Thyroid Biodistribution of 123I-CMICE-013 Post Stress Imaging n = 12
Biodistribution of 123I-CMICE-013 Immediately after injection	0.8 (0.2)	0.5 (0.1)
Biodistribution 90 min post 123I-CMICE-013 injection	0.7 (0.3)	0.5 (0.1)
Biodistribution 4 hours post 123I-CMICE-013 injection	0.6 (0.3)	0.4 (0.1)
Biodistribution 6 hours post 123I-CMICE-013 injection	0.5 (0.3)	0.3 (0.1)
Biodistribution 24 hours post 123I-CMICE-013 injection	0.1 (0.1)	0.1 (0)

Population analysed: Normal, healthy volunteers, with no pre-existing medical conditions were recruited. The volunteers were six (6) males and six (6) females and ranged from 18 to 42 years of age.

Primary outcome: Biodistribution of the 123I-CMICE-013 Within the Heart Wall

Measure	Heart Wall Biodistribution of 123I-CMICE-013 Post Rest Imaging n = 12	Heart Wall Biodistribution of 123I-CMICE-013 Post Stress Imaging n = 12
Biodistribution of 123I-CMICE-013 Immediately after injection	5.0 (0.6)	3.2 (0.6)
Biodistribution after 90 min post 123I-CMICE-013 injection	4.0 (0.4)	2.6 (0.5)
Biodistribution after 4 hours post 123I-CMICE-013 injection	2.7 (0.3)	2.0 (0.4)
Biodistribution after 6 hours post 123I-CMICE-013 injection	2.1 (0.3)	1.6 (0.3)
Biodistribution after 24 hours post 123I-CMICE-013 injection	0.3 (0.1)	0.4 (0.1)

Population analysed: Normal, healthy volunteers, with no pre-existing medical conditions were recruited. The volunteers were six (6) males and six (6) females and ranged from 18 to 42 years of age.

Primary outcome: Biodistribution of the 123I-CMICE-013 Within the Bladder

Measure	Bladder Biodistribution of 123I-CMICE-013 Post Rest Imaging n = 12	Bladder Biodistribution of 123I-CMICE-013 Post Stress Imaging n = 12
Biodistribution of 123I-CMICE-013 Immediately after injection	3.6 (0.6)	2.3 (0.6)
Biodistribution 90 min post 123I-CMICE-013 injection	5.3 (1.9)	4.7 (1.8)
Biodistribution 4 hours post 123I-CMICE-013 injection	6.9 (3.9)	4.8 (2.8)
Biodistribution 6 hours post 123I-CMICE-013 injection	6.0 (4.4)	4.8 (2.8)
Biodistribution 24 hours post 123I-CMICE-013 injection	0.8 (0.3)	1.0 (0.4)

Population analysed: Normal, healthy volunteers, with no pre-existing medical conditions were recruited. The volunteers were six (6) males and six (6) females and ranged from 18 to 42 years of age.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
123I-CMICE-013 Rest Dose	0 of 12 (0%)	2 of 12 (16.7%)	0 of 12
123I-CMICE-013 Stress Dose	0 of 12 (0%)	2 of 12 (16.7%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Terrence D Ruddy, MD principal investigator

Ottawa Heart Institute Research Corporation

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 123I-CMICE-013 in people with Coronary Artery Disease, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01558362.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.