Comparison Between Myocardial Tomoscintigraphies Using a Semiconductor Camera or a Conventional Camera (DSPECT)

August 5, 2016 updated by: Central Hospital, Nancy, France

Comparison Between Myocardial Tomoscintigraphies Using a Semiconductor Camera or a Conventional Camera According to Conditions of Examination Execution: Assessment of Infarction or Ischemia, Injected Dye and Sequence of Injections

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Actual)

276

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France
        • Service de Médecine Nucléaire, Hôpital de Bichat, Assistance Publique des Hôpitaux de Paris
      • Toulouse, France
        • Service de Médecine Nucléaire, Clinique Louis Pasteur
      • Vandoeuvre-les-Nancy, France
        • Service de Médecine Nucléaire, Hôpital de Brabois, CHU de Nancy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1. stress thallium-201 tomoscintigraphy
Other: Stress thallium-201 tomoscintigraphy, followed by a second rest tomoscintigraphy if necessary
with gamma-camera and D.SPECT camera
Experimental: 2. stress technetium-99m tomoscintigraphy 1
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
Experimental: 3. stress technetium-99m tomoscintigraphy 2
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
Experimental: 4. stress technetium-99m tomoscintigraphy 3
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
Experimental: 5. rest thallium-201 tomoscintigraphy
Other: Rest thallium-201 tomoscintigraphy with gamma-camera and D.SPECT camera
rest thallium-201 tomoscintigraphy for myocardial viability assessment
Experimental: 6. rest technetium-99m tomoscintigraphy
Other: Rest technetium-99m tomoscintigraphy with gamma-camera and D.SPECT camera
rest technetium-99m tomoscintigraphy for myocardial viability assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ejection fraction of link ventricle
Time Frame: day 0
day 0
Telesystolic volume of link ventricle
Time Frame: day 0
day 0
Telediastolic volume of link ventricle
Time Frame: day 0
day 0
Diagnosis of stress ischemia with Myocardial Tomoscintigraphy data
Time Frame: day 0
day 0
Area of damaged regions of heart
Time Frame: day 0
day 0

Secondary Outcome Measures

Outcome Measure
Time Frame
Global myocardial activity
Time Frame: day 0
day 0
Qualitative score of image quality
Time Frame: day 0
day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Investigators

  • Principal Investigator: Wassilia DJABALLAH, Service de Médecine Nucléaire, Hôpital de Brabois, 54500, Vandoeuvre-les-Nancy, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

July 29, 2016

First Submitted That Met QC Criteria

August 5, 2016

First Posted (Estimate)

August 10, 2016

Study Record Updates

Last Update Posted (Estimate)

August 10, 2016

Last Update Submitted That Met QC Criteria

August 5, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-A00422-55

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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