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

NCT01558362 | Completed Phase 1 Results

• 1 other identifier: 20120080-01H
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

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

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

Secondary Outcomes (2)

• 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.

• 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.

Study Arms (1)

123I-CMICE-013

EXPERIMENTAL

Administration and analysis of alternative MPI radiotracer

Drug: 123I-CMICE-013

Interventions

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.

123I-CMICE-013

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

CMICE-013

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Results Point of Contact

• Title: Dr. Terrence Ruddy, Principal Investigator
• Organization: University of Ottawa Heart Institute

truddy@ottawaheart.ca

613-696-7267

Study Officials

• Terrence D Ruddy, MD

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2012
• First Posted: March 20, 2012
• Study Start: April 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: March 26, 2025
• Results First Posted: March 26, 2025

Record last verified: 2025-01

Locations

CA (1)