Trial Outcomes & Findings for A Study of 123I-CMICE-013 Radiopharmaceutical in Healthy Volunteers (NCT NCT01558362)
NCT ID: NCT01558362
Last Updated: 2025-03-26
Results Overview
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.
COMPLETED
PHASE1
12 participants
From enrollment to completion of imaging was 24 hours for each scan. Rest and stress scans were performed one week apart.
2025-03-26
Participant Flow
12 healthy normal volunteers will be recruited to complete the study.
Participant milestones
| Measure |
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.
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|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of 123I-CMICE-013 Radiopharmaceutical in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
123I-CMICE-013
n=12 Participants
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.
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|---|---|
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Age, Continuous
|
24 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
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12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From enrollment to completion of imaging was 24 hours for each scan. Rest and stress scans were performed one week apart.Population: 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.
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.
Outcome measures
| Measure |
Lung Biodistribution of 123I-CMICE-013 Post Rest Imaging
n=12 Participants
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.
|
Lung Biodistribution of 123I-CMICE-013 Post Stress Imaging
n=12 Participants
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.
|
|---|---|---|
|
Biodistribution of the 123I-CMICE-013 Within the Lungs
Biodistribution immediately after 123I-CMICE-013 injection.
|
8.4 percentage of total injected dose
Standard Deviation 1.9
|
7.1 percentage of total injected dose
Standard Deviation 1.1
|
|
Biodistribution of the 123I-CMICE-013 Within the Lungs
Biodistribution at 90 min post 123I-CMICE-013 injection
|
7.1 percentage of total injected dose
Standard Deviation 1.8
|
6.2 percentage of total injected dose
Standard Deviation 1.0
|
|
Biodistribution of the 123I-CMICE-013 Within the Lungs
Biodistribution at 4 hours post 123I-CMICE-013 injection
|
5.3 percentage of total injected dose
Standard Deviation 1.4
|
4.8 percentage of total injected dose
Standard Deviation 0.9
|
|
Biodistribution of the 123I-CMICE-013 Within the Lungs
Biodistribution at 6 hours post 123I-CMICE-013 injection
|
4.3 percentage of total injected dose
Standard Deviation 1.1
|
4.1 percentage of total injected dose
Standard Deviation 0.8
|
|
Biodistribution of the 123I-CMICE-013 Within the Lungs
Biodistribution at 24 hours post 123I-CMICE-013 injection
|
0.8 percentage of total injected dose
Standard Deviation 0.2
|
1.0 percentage of total injected dose
Standard Deviation 0.2
|
PRIMARY outcome
Timeframe: From enrollment to completion of imaging was 24 hours for each scan. Rest and stress scans were performed one week apart.Population: 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.
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.
Outcome measures
| Measure |
Lung Biodistribution of 123I-CMICE-013 Post Rest Imaging
n=12 Participants
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.
|
Lung Biodistribution of 123I-CMICE-013 Post Stress Imaging
n=12 Participants
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.
|
|---|---|---|
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Biodistribution of the 123I-CMICE-013 Within the Thyroid
Biodistribution of 123I-CMICE-013 Immediately after injection
|
0.8 percentage of total injected dose
Standard Deviation 0.2
|
0.5 percentage of total injected dose
Standard Deviation 0.1
|
|
Biodistribution of the 123I-CMICE-013 Within the Thyroid
Biodistribution 90 min post 123I-CMICE-013 injection
|
0.7 percentage of total injected dose
Standard Deviation 0.3
|
0.5 percentage of total injected dose
Standard Deviation 0.1
|
|
Biodistribution of the 123I-CMICE-013 Within the Thyroid
Biodistribution 4 hours post 123I-CMICE-013 injection
|
0.6 percentage of total injected dose
Standard Deviation 0.3
|
0.4 percentage of total injected dose
Standard Deviation 0.1
|
|
Biodistribution of the 123I-CMICE-013 Within the Thyroid
Biodistribution 6 hours post 123I-CMICE-013 injection
|
0.5 percentage of total injected dose
Standard Deviation 0.3
|
0.3 percentage of total injected dose
Standard Deviation 0.1
|
|
Biodistribution of the 123I-CMICE-013 Within the Thyroid
Biodistribution 24 hours post 123I-CMICE-013 injection
|
0.1 percentage of total injected dose
Standard Deviation 0.1
|
0.1 percentage of total injected dose
Standard Deviation 0
|
PRIMARY outcome
Timeframe: From enrollment to completion of imaging was 24 hours for each scan. Rest and stress scans were performed one week apart.Population: 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.
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.
Outcome measures
| Measure |
Lung Biodistribution of 123I-CMICE-013 Post Rest Imaging
n=12 Participants
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.
|
Lung Biodistribution of 123I-CMICE-013 Post Stress Imaging
n=12 Participants
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.
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|---|---|---|
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Biodistribution of the 123I-CMICE-013 Within the Heart Wall
Biodistribution of 123I-CMICE-013 Immediately after injection
|
5.0 percentage of total injected dose
Standard Deviation 0.6
|
3.2 percentage of total injected dose
Standard Deviation 0.6
|
|
Biodistribution of the 123I-CMICE-013 Within the Heart Wall
Biodistribution after 90 min post 123I-CMICE-013 injection
|
4.0 percentage of total injected dose
Standard Deviation 0.4
|
2.6 percentage of total injected dose
Standard Deviation 0.5
|
|
Biodistribution of the 123I-CMICE-013 Within the Heart Wall
Biodistribution after 4 hours post 123I-CMICE-013 injection
|
2.7 percentage of total injected dose
Standard Deviation 0.3
|
2.0 percentage of total injected dose
Standard Deviation 0.4
|
|
Biodistribution of the 123I-CMICE-013 Within the Heart Wall
Biodistribution after 6 hours post 123I-CMICE-013 injection
|
2.1 percentage of total injected dose
Standard Deviation 0.3
|
1.6 percentage of total injected dose
Standard Deviation 0.3
|
|
Biodistribution of the 123I-CMICE-013 Within the Heart Wall
Biodistribution after 24 hours post 123I-CMICE-013 injection
|
0.3 percentage of total injected dose
Standard Deviation 0.1
|
0.4 percentage of total injected dose
Standard Deviation 0.1
|
PRIMARY outcome
Timeframe: From enrollment to completion of imaging was 24 hours for each scan. Rest and stress scans were performed one week apart.Population: 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.
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.
Outcome measures
| Measure |
Lung Biodistribution of 123I-CMICE-013 Post Rest Imaging
n=12 Participants
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.
|
Lung Biodistribution of 123I-CMICE-013 Post Stress Imaging
n=12 Participants
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.
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|---|---|---|
|
Biodistribution of the 123I-CMICE-013 Within the Bladder
Biodistribution of 123I-CMICE-013 Immediately after injection
|
3.6 percentage of total injected dose
Standard Deviation 0.6
|
2.3 percentage of total injected dose
Standard Deviation 0.6
|
|
Biodistribution of the 123I-CMICE-013 Within the Bladder
Biodistribution 90 min post 123I-CMICE-013 injection
|
5.3 percentage of total injected dose
Standard Deviation 1.9
|
4.7 percentage of total injected dose
Standard Deviation 1.8
|
|
Biodistribution of the 123I-CMICE-013 Within the Bladder
Biodistribution 4 hours post 123I-CMICE-013 injection
|
6.9 percentage of total injected dose
Standard Deviation 3.9
|
4.8 percentage of total injected dose
Standard Deviation 2.8
|
|
Biodistribution of the 123I-CMICE-013 Within the Bladder
Biodistribution 6 hours post 123I-CMICE-013 injection
|
6.0 percentage of total injected dose
Standard Deviation 4.4
|
4.8 percentage of total injected dose
Standard Deviation 2.8
|
|
Biodistribution of the 123I-CMICE-013 Within the Bladder
Biodistribution 24 hours post 123I-CMICE-013 injection
|
0.8 percentage of total injected dose
Standard Deviation 0.3
|
1.0 percentage of total injected dose
Standard Deviation 0.4
|
PRIMARY outcome
Timeframe: From enrollment to completion of imaging was 24 hours for each scan. Rest and stress scans were performed one week apart.Population: 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.
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.
Outcome measures
| Measure |
Lung Biodistribution of 123I-CMICE-013 Post Rest Imaging
n=12 Participants
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.
|
Lung Biodistribution of 123I-CMICE-013 Post Stress Imaging
n=12 Participants
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.
|
|---|---|---|
|
Biodistribution of the 123I-CMICE-013 Within the Liver
Biodistribution of 123I-CMICE-013 Immediately after injection
|
14.4 percentage of total injected dose
Standard Deviation 2.1
|
9.0 percentage of total injected dose
Standard Deviation 1.2
|
|
Biodistribution of the 123I-CMICE-013 Within the Liver
Biodistribution 90 min post 123I-CMICE-013 injection
|
8.4 percentage of total injected dose
Standard Deviation 0.9
|
5.9 percentage of total injected dose
Standard Deviation 0.9
|
|
Biodistribution of the 123I-CMICE-013 Within the Liver
Biodistribution 4 hours post 123I-CMICE-013 injection
|
5.4 percentage of total injected dose
Standard Deviation 0.9
|
4.3 percentage of total injected dose
Standard Deviation 0.9
|
|
Biodistribution of the 123I-CMICE-013 Within the Liver
Biodistribution 6 hours post 123I-CMICE-013 injection
|
4.2 percentage of total injected dose
Standard Deviation 1.0
|
3.7 percentage of total injected dose
Standard Deviation 0.9
|
|
Biodistribution of the 123I-CMICE-013 Within the Liver
Biodistribution 24 hours post 123I-CMICE-013 injection
|
0.7 percentage of total injected dose
Standard Deviation 0.2
|
0.8 percentage of total injected dose
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: From enrollment to completion of imaging was 24 hours for each scan. Rest and stress scans were performed one week apart.Population: 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.
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.
Outcome measures
| Measure |
Lung Biodistribution of 123I-CMICE-013 Post Rest Imaging
n=6 Participants
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.
|
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.
|
|---|---|---|
|
Total Effective Dose of 123I-CMICE-013 for Men
Total Effective Dose of 123I-CMICE-013 during Rest Imaging
|
24.0 microsieverts per megabecquerel
Standard Deviation 5.0
|
—
|
|
Total Effective Dose of 123I-CMICE-013 for Men
Total Effective Dose of 123I-CMICE-013 during Stress Imaging
|
23.0 microsieverts per megabecquerel
Standard Deviation 4.0
|
—
|
SECONDARY outcome
Timeframe: From enrollment to completion of imaging was 24 hours for each scan. Rest and stress scans were performed one week apart.Population: 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.
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.
Outcome measures
| Measure |
Lung Biodistribution of 123I-CMICE-013 Post Rest Imaging
n=6 Participants
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.
|
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.
|
|---|---|---|
|
Total Effective Dose of 123I-CMICE-013 for Women
Total Effective Dose of 123I-CMICE-013 during Rest Imaging
|
30.0 microsieverts per megabecquerel
Standard Deviation 2.0
|
—
|
|
Total Effective Dose of 123I-CMICE-013 for Women
Total Effective Dose of 123I-CMICE-013 during stress Imaging
|
29.0 microsieverts per megabecquerel
Standard Deviation 2.0
|
—
|
Adverse Events
123I-CMICE-013 Rest Dose
123I-CMICE-013 Stress Dose
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
123I-CMICE-013 Rest Dose
n=12 participants at risk
One resting dose of 185MBq administered on Day 1 of study participation.
|
123I-CMICE-013 Stress Dose
n=12 participants at risk
One stress dose of 185MBq administered on Day 8 of study participation.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Leg Injury
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
skin irritation
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Pressure spot
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
Additional Information
Dr. Terrence Ruddy, Principal Investigator
University of Ottawa Heart Institute
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place