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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01558362

Acronym

CMICE

Enrollment

Registered

2012-03-20

Start date

2012-04-30

Completion date

2012-09-30

Last updated

2025-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

myocardial perfusion imaging, single photon emission tomography, Coronary artery disease, gamma camera imaging, Phase 1 clinical trial, cyclotron

Brief 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.

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.

Interventions

DRUG123I-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. All volunteers had a rest dose first followed by a stress dose.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

1. Age between 18 and 65 years 2. No significant medical history 3. Normal physical exam 4. BMI ≤ 30 kg/m2 5. No current use of prescription medication 6. No clinically significant abnormalities in baseline laboratory work 7. No clinically significant abnormalities in baseline 12 lead electrocardiogram 8. Female subjects must be post-menopausal, surgically sterilized or have negative urine beta human chorionic gonadotropin pregnancy test at initial screening

Exclusion criteria

1. Pregnancy 2. Known hypersensitivity to the investigational drug or any of its components 3. Claustrophobia or inability to lie still in a supine position 4. Unwillingness to provide informed consent

Design outcomes

Primary

Measure	Time frame	Description
Biodistribution of the 123I-CMICE-013 Within the Thyroid	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 Bladder	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	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 Lungs	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	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.

Secondary

Measure	Time frame	Description
Total Effective Dose of 123I-CMICE-013 for Women	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.
Total Effective Dose of 123I-CMICE-013 for Men	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.

Countries

Canada

Participant flow

Recruitment details

12 healthy normal volunteers will be recruited to complete the study.

Participants by arm

Arm	Count
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.	12
Total	12

Baseline characteristics

Characteristic	123I-CMICE-013
Age, Continuous	24 years
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	2 Participants
Race (NIH/OMB) Black or African American	0 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	10 Participants
Region of Enrollment Canada	12 participants
Sex: Female, Male Female	6 Participants
Sex: Female, Male Male	6 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 12	0 / 12
other Total, other adverse events	2 / 12	2 / 12
serious Total, serious adverse events	0 / 12	0 / 12

Outcome results

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.