Back to resultsA Phase I Study of a Novel Tracer for Positron Emission Tomography "PET" Myocardial Perfusion Imaging "MPI"
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
[11C]-DMDPA
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary Artery Disease
Eligibility Criteria
Inclusion Criteria:
- body mass index (BMI) between 18.0 and 30.0 kg/m2
- good health
- written informed consent
Exclusion Criteria:
- smokers
- subject receiving medication
- a blood transfusion in the 4 weeks prior to screening
- positive alcohol blood test
- Subjects who suffer from claustrophobia
- Subjects who have had a clinically significant illness
- Subjects exposed to radiation within 12 months prior to screening
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A single Intravenous bolus injection
Arm Description
A single Intravenous bolus injection of 11C[DMDPA]
Outcomes
Primary Outcome Measures
Measurement of absorbed radiation dose for all target organs in megabecquerel (the activity of a quantity of radioactive material in which one nucleus decays per second).
Secondary Outcome Measures
Full Information
NCT ID
NCT02720354
First Posted
March 15, 2016
Last Updated
October 18, 2017
Sponsor
Synektik S.A.
Collaborators
European Commission
1. Study Identification
Unique Protocol Identification Number
NCT02720354
Brief Title
A Phase I Study of a Novel Tracer for Positron Emission Tomography "PET" Myocardial Perfusion Imaging "MPI"
Official Title
A Phase I Study of a Novel Tracer for Positron Emission Tomography "PET" Myocardial Perfusion Imaging "MPI"
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
May 2016 (Actual)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
May 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Synektik S.A.
Collaborators
European Commission
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
[11C]-dimethyl-diphenyl ammonium ([11C]-DMDPA) - A Phase I, Open-label, Safety and Tolerability, Radiation Dosimetry, Biodistribution, First-in-Human Study of a Novel 11C-labeled Tracer for Positron Emission Tomography Myocardial Perfusion Imaging
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A single Intravenous bolus injection
Arm Type
Experimental
Arm Description
A single Intravenous bolus injection of 11C[DMDPA]
Intervention Type
Other
Intervention Name(s)
[11C]-DMDPA
Primary Outcome Measure Information:
Title
Measurement of absorbed radiation dose for all target organs in megabecquerel (the activity of a quantity of radioactive material in which one nucleus decays per second).
Time Frame
within 80 minutes
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
body mass index (BMI) between 18.0 and 30.0 kg/m2
good health
written informed consent
Exclusion Criteria:
smokers
subject receiving medication
a blood transfusion in the 4 weeks prior to screening
positive alcohol blood test
Subjects who suffer from claustrophobia
Subjects who have had a clinically significant illness
Subjects exposed to radiation within 12 months prior to screening
12. IPD Sharing Statement
Learn more about this trial
A Phase I Study of a Novel Tracer for Positron Emission Tomography "PET" Myocardial Perfusion Imaging "MPI"
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