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

NCT ID: NCT02720354

Last Updated: 2017-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2017-05-31

Brief Summary

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\[11C\]-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

Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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A single Intravenous bolus injection

A single Intravenous bolus injection of 11C\[DMDPA\]

Group Type EXPERIMENTAL

[11C]-DMDPA

Intervention Type OTHER

Interventions

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[11C]-DMDPA

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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European Commission

OTHER

Sponsor Role collaborator

Synektik S.A.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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SK-DMDPA-001

Identifier Type: -

Identifier Source: org_study_id