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A Phase I Study of a Novel Tracer for Positron Emission Tomography PET Myocardial Perfusion Imaging MPI

A Phase I Study of a Novel Tracer for Positron Emission Tomography PET Myocardial Perfusion Imaging MPI

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02720354
Enrollment
12
Registered
2016-03-25
Start date
2016-05-31
Completion date
2017-05-31
Last updated
2017-10-20

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

Conditions

Coronary Artery Disease

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

Interventions

OTHER[11C]-DMDPA

Sponsors

European Commission
CollaboratorOTHER
Synektik S.A.
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
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).within 80 minutes

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026