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Completed

NCT Number: NCT02861235

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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).

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

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

Other

with gamma-camera and D.SPECT camera

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

Other

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

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

Other

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

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

Other

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

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

Other

rest thallium-201 tomoscintigraphy for myocardial viability assessment

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

Other

rest technetium-99m tomoscintigraphy for myocardial viability assessment

Primary outcomes

  1. Ejection fraction of link ventricle

    Time frame: day 0

  2. Telesystolic volume of link ventricle

    Time frame: day 0

  3. Telediastolic volume of link ventricle

    Time frame: day 0

  4. Diagnosis of stress ischemia with Myocardial Tomoscintigraphy data

    Time frame: day 0

  5. Area of damaged regions of heart

    Time frame: day 0

Secondary outcomes

  1. Global myocardial activity

    Time frame: day 0

  2. Qualitative score of image quality

    Time frame: day 0

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

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

Acronym: DSPECT

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Aug 10, 2016
Registry last updated
Aug 10, 2016

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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