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

Cardiac Function Clinical Trial

— STARGAC  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04629937
• Other study ID #: CHRO 2020-20
• Status: Completed
• Phase: N/A
• Start date: December 30, 2020
• Est. completion date: August 6, 2021

Study information

• Verified date: July 2022
• Source: Centre Hospitalier Régional d'Orléans
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: August 6, 2021
• Est. primary completion date: August 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Function

Intervention

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

Locations

Country	Name	City	State
France	CHR d'Orleans	Orléans

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Régional d'Orléans

Country where clinical trial is conducted

France, 

References & Publications (6)

Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12. Erratum in: CA Cancer J Clin. 2020 Jul;70(4):313. — View Citation

Carver JR, Shapiro CL, Ng A, Jacobs L, Schwartz C, Virgo KS, Hagerty KL, Somerfield MR, Vaughn DJ; ASCO Cancer Survivorship Expert Panel. American Society of Clinical Oncology clinical evidence review on the ongoing care of adult cancer survivors: cardiac and pulmonary late effects. J Clin Oncol. 2007 Sep 1;25(25):3991-4008. Epub 2007 Jun 18. Review. — View 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. — View Citation

Garcia EV, Faber TL, Esteves FP. Cardiac dedicated ultrafast SPECT cameras: new designs and clinical implications. J Nucl Med. 2011 Feb;52(2):210-7. doi: 10.2967/jnumed.110.081323. Epub 2011 Jan 13. Review. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of left and right ventricular volumes and ejection fraction.	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).	Day 0
Secondary	Assessment of left and ventricular volumes and ejection fraction with attenuation correction.	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).	Day 0