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Completed

NCT Number: NCT04629937

Evaluation of Whole-body CZT Camera in Gated Tomographic Radionuclide Angiography

Tomographic radionuclide angiography (or blood pool) is a reproducible method to evaluate left ventricular ejection fraction that is needed during oncological treatments or to evaluate cardiopathies.

Cardiac-dedicated CZT systems allowed dose or time reduction. Multipurpose CZT cameras have not yet been evaluated in this indication. Moreover, the impact of attenuation correction is not known.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHR d'Orleans

Orléans, 45067, France

About this study

Tomographic radionuclide angiography is a simple, rapid and reproducible method of cardiac function measurement, including left (LVEF) and right (RVEF) ventricular ejection fractions.

In addition to cardiological indications, this examination is often performed as part of cardiac toxicity screening during the various oncological treatments. This indication is all the more true since the arrival of CZT gamma cameras dedicated to cardiological studies has made it possible to reduce injected activities, as well as examination times.

The multipurpose CZT camera allows tomoscintigraphic acquisitions to be carried out using CZT technology as well. Unlike the CZT gamma cameras dedicated to cardiological studies, this system can be used for the exploration of different organs, and also allows the realization of CT slices for attenuation correction.

Patients included in this study will be double scanned both on a dedicated cardiac CZT camera and on multipurpose CZT camera, with CT. LVEF and RVEF will be then compared.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients referred to our Nuclear Medicine department for evaluation of cardiac function.

Exclusion criteria

  • Patients treated with chemotherapy within 12 days.
  • Under 18 years old patients.
  • Pregnant women or at risk of pregnancy.
  • Breast feeding.
  • Painful patients.
  • Patients under guardianship.
  • Patients in whom a standard examination is not feasible (agitation).
  • Patients who do not benefit from a social security system

Treatment and study plan

SPECT acquisitions

Other

All patients will undergo SPECT acquisitions with both multipurpose CZT camera and cardiac dedicated CZT camera.

Primary outcomes

  1. Assessment of left and right ventricular volumes and ejection fraction.

    Time frame: Day 0

    Automatic quantification of left and right ventricular volumes, left ventricle ejection fraction (LVEF) and right ventricle ejection fraction (RVEF) using BPGs software (Cedars-Sinai Medical Center, Los Angeles, USA).

Secondary outcomes

  1. Assessment of left and ventricular volumes and ejection fraction with attenuation correction.

    Time frame: Day 0

    Assessment of an attenuation map from low dose CT data. Automatic quantification of left and right ventricular volumes, LVEF and RVEF using BPGs software (Cedars-Sinai Medical Center, Los Angeles, USA).

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional d'Orléans

Other

Registry information

Official study title

Clinical Evaluation of a Multipurpose CZT Camera in Gated Tomographic Radionuclide Angiography: a Head to Head Comparison With a Cardiac Dedicated CZT Device

Acronym: STARGAC

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 16, 2020
Registry last updated
Jul 18, 2022

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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