Comparison Between Myocardial Tomoscintigraphies Using a Semiconductor Camera or a Conventional Camera

NCT ID: NCT02861235

Last Updated: 2016-08-10

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

NA

Total Enrollment

276 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-05-31

Brief Summary

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Myocardial perfusion tomoscintigraphy is a routine medicine procedure to check for the presence and severity of abnormalities of myocardial perfusion, as well as the extension of infarction residua. However, actual imagery devices (gamma cameras) have low resolution and detection sensitivity. A new semiconductor camera has 8 to 10 time higher detection sensitivity and could allow proportionally diminishing injected activities or recording times. Only one pilot study has been recently published on this type of camera, the D.SPECT camera.

This study will compare images recorded during 15 to 20 minutes by conventional cameras and 2 to 4 minutes by D.SPECT camera in patients doing tomoscintigraphy under usual conditions. The purpose is to demonstrate the equivalence of images recorded by two camera types for diagnostic information and the secondary purpose is to demonstrate the superiority of the D.SPECT camera in terms of image quality.

Detailed Description

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This study will be conducted in Nuclear Medicine departments (Nancy Hospital, Bichat Hospital in Paris, Pasteur private hospital in Toulouse), with D.SPECT camera (Cyclopharma). The D.SPECT camera recording will be realized following the conventional camera recording and will not modify the routine programmed examination. Recording times of D.SPECT camera will be maximum 2 minutes for imaging with a strong activity of technetium-99m labeled dye and maximum 4 minutes for imaging with thallium-201 or with a low activity of technetium-99m labeled dye.6 study groups will be analyzed: 4 groups of patients initially doing stress tomoscintigraphy with thallium-201 (group 1) or with technetium-99m labeled dye and then testing 3 principal injection sequences (group 2, 3, 4), and 2 groups of patients initially doing "myocardial viability" assessment with rest tomoscintigraphy with thallium-201 (group 5) or technetium-99m labeled dye.

Recording comparison obtained with 2 cameras will be done according to qualitative and quantitative criteria on image quality and analyzing diagnosis concordance (presence, type and severity of observed abnormalities).

Conditions

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Myocardial Infarction Ischemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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1. stress thallium-201 tomoscintigraphy

Group Type EXPERIMENTAL

Stress thallium-201 tomoscintigraphy, followed by a second rest tomoscintigraphy if necessary

Intervention Type OTHER

with gamma-camera and D.SPECT camera

2. stress technetium-99m tomoscintigraphy 1

Group Type EXPERIMENTAL

Rest technetium-99m tomoscintigraphy followed by stress technetium-99m tomoscintigraphy on the same day

Intervention Type OTHER

with gamma-camera and D.SPECT camera, in Toulouse centre

3. stress technetium-99m tomoscintigraphy 2

Group Type EXPERIMENTAL

Stress technetium-99m tomoscintigraphy followed by rest technetium-99m tomoscintigraphy on the same day

Intervention Type OTHER

with gamma-camera and D.SPECT camera, in Nancy centre

4. stress technetium-99m tomoscintigraphy 3

Group Type EXPERIMENTAL

stress technetium-99m tomoscintigraphy followed by rest technetium-99m tomoscintigraphy in two different days

Intervention Type OTHER

with gamma-camera and D.SPECT camera, in Paris centre

5. rest thallium-201 tomoscintigraphy

Group Type EXPERIMENTAL

Rest thallium-201 tomoscintigraphy with gamma-camera and D.SPECT camera

Intervention Type OTHER

rest thallium-201 tomoscintigraphy for myocardial viability assessment

6. rest technetium-99m tomoscintigraphy

Group Type EXPERIMENTAL

Rest technetium-99m tomoscintigraphy with gamma-camera and D.SPECT camera

Intervention Type OTHER

rest technetium-99m tomoscintigraphy for myocardial viability assessment

Interventions

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Stress thallium-201 tomoscintigraphy, followed by a second rest tomoscintigraphy if necessary

with gamma-camera and D.SPECT camera

Intervention Type OTHER

Rest technetium-99m tomoscintigraphy followed by stress technetium-99m tomoscintigraphy on the same day

with gamma-camera and D.SPECT camera, in Toulouse centre

Intervention Type OTHER

Stress technetium-99m tomoscintigraphy followed by rest technetium-99m tomoscintigraphy on the same day

with gamma-camera and D.SPECT camera, in Nancy centre

Intervention Type OTHER

stress technetium-99m tomoscintigraphy followed by rest technetium-99m tomoscintigraphy in two different days

with gamma-camera and D.SPECT camera, in Paris centre

Intervention Type OTHER

Rest thallium-201 tomoscintigraphy with gamma-camera and D.SPECT camera

rest thallium-201 tomoscintigraphy for myocardial viability assessment

Intervention Type OTHER

Rest technetium-99m tomoscintigraphy with gamma-camera and D.SPECT camera

rest technetium-99m tomoscintigraphy for myocardial viability assessment

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Understanding and signature of informed consent
* Without any contraindication for tomoscintigraphy and stress techniques according to French Society of Cardiology and Nuclear Medicine criteria, as established for all patients doing this routine examination
* Not in emergency situation and with a stable clinical status (without any sign of heart or coronary failure, without uncontrolled high blood pressure under treatment)
* Having an effective contraception for women of childbearing potential

Exclusion Criteria

* Patient under guardianship
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wassilia DJABALLAH

Role: PRINCIPAL_INVESTIGATOR

Service de Médecine Nucléaire, Hôpital de Brabois, 54500, Vandoeuvre-les-Nancy, France

Locations

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Service de Médecine Nucléaire, Hôpital de Bichat, Assistance Publique des Hôpitaux de Paris

Paris, , France

Site Status

Service de Médecine Nucléaire, Clinique Louis Pasteur

Toulouse, , France

Site Status

Service de Médecine Nucléaire, Hôpital de Brabois, CHU de Nancy

Vandœuvre-lès-Nancy, , France

Site Status

Countries

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France

Other Identifiers

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2009-A00422-55

Identifier Type: -

Identifier Source: org_study_id

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