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OpenTrials
Completed

NCT Number: NCT02720354

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

[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

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Key information

Conditions

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

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

[11C]-DMDPA

Other

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Synektik S.A.

Industry

Collaborators

  • European Commission

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 25, 2016
Registry last updated
Oct 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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