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

Not Applicable

Completed

• Conditions: Cardiac Function
• Interventions: Other: SPECT acquisitions

• Registration Number: NCT04629937
• Lead Sponsor: Centre Hospitalier Régional d'Orléans

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2020-11-10
• Study First Submitted QC: 2020-11-13
• Study First Posted: 2020-11-16
• Study Start: 2020-12-30
• Primary Completion: 2021-08-06
• Study Completion: 2021-08-06
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-15
• Last Update Posted: 2022-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Assessment of left and right ventricular volumes and ejection fraction.	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 Outcome Measures

Name	Time	Method
Assessment of left and ventricular volumes and ejection fraction with attenuation correction.	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).

Trial Locations

Locations (1)

CHR d'Orleans; 🇫🇷 Orléans, France