Clinical trial NCT01558362: A Study of 123I-CMICE-013 Radiopharmaceutical in Healthy Volunteers
Official title: A Phase 1 Study of Safety, Tolerance, Pharmacokinetics and Nuclear Medicine Imaging of 123I-CMICE-013 Administered Intravenously in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Coronary Artery Disease
Keywords: myocardial perfusion imaging
single photon emission tomography
Coronary artery disease
gamma camera imaging
Phase 1 clinical trial
cyclotron
Lead sponsor: Ottawa Heart Institute Research Corporation
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2012-03-20
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Biodistribution of the 123I-CMICE-013 Within the Lungs
timeFrame: From enrollment to completion of imaging was 24 hours for each scan. Rest and stress scans were performed one week apart.
measure: Biodistribution of the 123I-CMICE-013 Within the Thyroid
timeFrame: From enrollment to completion of imaging was 24 hours for each scan. Rest and stress scans were performed one week apart.
measure: Biodistribution of the 123I-CMICE-013 Within the Heart Wall
timeFrame: From enrollment to completion of imaging was 24 hours for each scan. Rest and stress scans were performed one week apart.
measure: Biodistribution of the 123I-CMICE-013 Within the Bladder
timeFrame: From enrollment to completion of imaging was 24 hours for each scan. Rest and stress scans were performed one week apart.
measure: Biodistribution of the 123I-CMICE-013 Within the Liver
timeFrame: From enrollment to completion of imaging was 24 hours for each scan. Rest and stress scans were performed one week apart.
Secondary outcomes:
measure: Total Effective Dose of 123I-CMICE-013 for Men
timeFrame: From enrollment to completion of imaging was 24 hours for each scan. Rest and stress scans were performed one week apart.
measure: Total Effective Dose of 123I-CMICE-013 for Women
timeFrame: From enrollment to completion of imaging was 24 hours for each scan. Rest and stress scans were performed one week apart.
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
Study officials:
affiliation: Ottawa Heart Institute Research Corporation
name: Terrence D Ruddy, MD
role: PRINCIPAL_INVESTIGATOR
References: