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

Phase 1

Completed

Conditions: Coronary Artery Disease

Interventions: Drug: 123I-CMICE-013

Registration Number: NCT01558362

Lead Sponsor: Ottawa Heart Institute Research Corporation

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 12

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
123I-CMICE-013	123I-CMICE-013	Administration and analysis of alternative MPI radiotracer

Primary Outcome Measures

Name	Time	Method
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 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 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.
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.

Secondary Outcome Measures

Name	Time	Method
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.
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.