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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 123I-CMICE-013 | Experimental | Administration and analysis of alternative MPI radiotracer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Terrence D Ruddy, MD | Ottawa Heart Institute Research Corporation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Ottawa Heart Institute | Ottawa | Ontario | K1Y 4W7 | Canada |
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12 healthy normal volunteers will be recruited to complete the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | 123I-CMICE-013 | Administration and analysis of alternative MPI radiotracer 123I-CMICE-013: 2 identical doses of intravenous drug will be given one week apart. Rest imaging will follow the initial dose. Exercise treadmill stress testing will follow the second dose. Serial nuclear imaging will follow dose injections. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 123I-CMICE-013 | Administration and analysis of alternative MPI radiotracer 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | percentage of total injected dose | From enrollment to completion of imaging was 24 hours for each scan. Rest and stress scans were performed one week apart. |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 123I-CMICE-013 Rest Dose | One resting dose of 185MBq administered on Day 1 of study participation. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leg Injury | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | participant injured leg while undergoing scan |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Terrence Ruddy, Principal Investigator | University of Ottawa Heart Institute | 613-696-7267 | truddy@ottawaheart.ca |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C000599676 | CMICE-013 |
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| 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. | From enrollment to completion of imaging was 24 hours for each scan. Rest and stress scans were performed one week apart. |
| 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. | From enrollment to completion of imaging was 24 hours for each scan. Rest and stress scans were performed one week apart. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Lung Biodistribution of 123I-CMICE-013 Post Stress Imaging | Administration and analysis of alternative MPI radiotracer For SPECT imaging at rest, patients were injected with a 190 +/- MBq dose of 123I-CMICE-013 injected as a single bolus over 10-20 sec followed by a saline flush. Patients underwent SPECT imaging immediately following injection, after 90 in, 4 hours, 6 hours, and 24 hours. Regions of interest were manually drawn on planar images. The biodistribution of the 123I-CMICE-013 at rest was calculated. |
|
|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | percentage of total injected dose | From enrollment to completion of imaging was 24 hours for each scan. Rest and stress scans were performed one week apart. |
|
|
|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | percentage of total injected dose | From enrollment to completion of imaging was 24 hours for each scan. Rest and stress scans were performed one week apart. |
|
|
|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | percentage of total injected dose | From enrollment to completion of imaging was 24 hours for each scan. Rest and stress scans were performed one week apart. |
|
|
|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | percentage of total injected dose | From enrollment to completion of imaging was 24 hours for each scan. Rest and stress scans were performed one week apart. |
|
|
|
| Secondary | 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. | Normal, healthy volunteers, with no pre-existing medical conditions were recruited. The volunteers were six (6) males and ranged from 18 to 42 years of age. | Posted | Mean | Standard Deviation | microsieverts per megabecquerel | From enrollment to completion of imaging was 24 hours for each scan. Rest and stress scans were performed one week apart. |
|
|
|
| Secondary | 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. | Normal, healthy volunteers, with no pre-existing medical conditions were recruited. The volunteers were six (6) females and ranged from 18 to 42 years of age. | Posted | Mean | Standard Deviation | microsieverts per megabecquerel | From enrollment to completion of imaging was 24 hours for each scan. Rest and stress scans were performed one week apart. |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 2 |
| 12 |
| EG001 | 123I-CMICE-013 Stress Dose | One stress dose of 185MBq administered on Day 8 of study participation. | 0 | 12 | 0 | 12 | 2 | 12 |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment | Patient became nauseated during the scan |
|
| skin irritation | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Skin became irritated around injection site |
|
| Pressure spot | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | pressure spot on buttocks after scan completed |
|
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| Biodistribution 4 hours post 123I-CMICE-013 injection |
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| Biodistribution 6 hours post 123I-CMICE-013 injection |
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| Biodistribution 24 hours post 123I-CMICE-013 injection |
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| Biodistribution after 4 hours post 123I-CMICE-013 injection |
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| Biodistribution after 6 hours post 123I-CMICE-013 injection |
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| Biodistribution after 24 hours post 123I-CMICE-013 injection |
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| Biodistribution 4 hours post 123I-CMICE-013 injection |
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| Biodistribution 6 hours post 123I-CMICE-013 injection |
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| Biodistribution 24 hours post 123I-CMICE-013 injection |
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| Biodistribution 4 hours post 123I-CMICE-013 injection |
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| Biodistribution 6 hours post 123I-CMICE-013 injection |
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| Biodistribution 24 hours post 123I-CMICE-013 injection |
|