Clinical trial NCT04629937: Evaluation of Whole-body CZT Camera in Gated Tomographic Radionuclide Angiography
Official title: Clinical Evaluation of a Multipurpose CZT Camera in Gated Tomographic Radionuclide Angiography: a Head to Head Comparison With a Cardiac Dedicated CZT Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Function
Keywords: SPECT
gated tomographic radionuclide angiography
Multipurpose CZT camera
left ventricle ejection fraction
Radionuclide angiography
Lead sponsor: Centre Hospitalier Régional d'Orléans
Sponsor class: OTHER
First posted: 2020-11-16
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All patients will undergo SPECT acquisitions with both multipurpose CZT camera and cardiac dedicated CZT camera.
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of left and right ventricular volumes and ejection fraction.
timeFrame: Day 0
Secondary outcomes:
measure: Assessment of left and ventricular volumes and ejection fraction with attenuation correction.
timeFrame: Day 0
Other outcomes:
Locations:
city: Orléans
country: France
facility: CHR d'Orleans
Study officials:
affiliation: CHR d'Orléans
name: Frédérique THIBAULT, Dr
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Curigliano G, Cardinale D, Suter T, Plataniotis G, de Azambuja E, Sandri MT, Criscitiello C, Goldhirsch A, Cipolla C, Roila F; ESMO Guidelines Working Group. Cardiovascular toxicity induced by chemotherapy, targeted agents and radiotherapy: ESMO Clinical Practice Guidelines. Ann Oncol. 2012 Oct;23 Suppl 7:vii155-66. doi: 10.1093/annonc/mds293.
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citation: Garcia EV. Are SPECT measurements of myocardial blood flow and flow reserve ready for clinical use? Eur J Nucl Med Mol Imaging. 2014 Dec;41(12):2291-3. doi: 10.1007/s00259-014-2924-2. No abstract available.
citation: Slomka PJ, Berman DS, Germano G. New cardiac cameras: single-photon emission CT and PET. Semin Nucl Med. 2014 Jul;44(4):232-51. doi: 10.1053/j.semnuclmed.2014.04.003.