Cardiac FunctionSTARGACNCT04629937
Evaluation of Whole-body CZT Camera in Gated Tomographic Radionuclide Angiography
A study testing SPECT acquisitions in people with Cardiac Function, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Function
- What is being tested?
- SPECT acquisitions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteFrance
- Study dates
- 30 Dec 2020to 6 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients referred to our Nuclear Medicine department for evaluation of cardiac function.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Cardiac Function
- Being tested
- SPECT acquisitions
- Keywords
- SPECT, gated tomographic radionuclide angiography, Multipurpose CZT camera, left ventricle ejection fraction, Radionuclide angiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPECT acquisitionsOther
All patients will undergo SPECT acquisitions with both multipurpose CZT camera and cardiac dedicated CZT camera.
| Study group | Role | What they receive |
|---|---|---|
| SPECT acquisitions | Experimental | All patients will undergo SPECT acquisitions with both multipurpose CZT camera and cardiac dedicated CZT camera. Receives: Other: SPECT acquisitions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Day 0
Secondary outcomes (1)
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).
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start30 Dec 2020
- Primary completion6 Aug 2021
- Study completion6 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cardiac FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All patients will undergo SPECT acquisitions with both multipurpose CZT camera and cardiac dedicated CZT camera.
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frédérique THIBAULT, Dr, Principal investigator, CHR d'Orléans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04629937
- Sponsor's protocol ID
- CHRO 2020-20
- Acronym
- STARGAC
- Status last verified
- Jul 2022
- First submitted
- 10 Nov 2020
- Last updated
- 18 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30207593Carver 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. doi: 10.1200/JCO.2007.10.9777. Epub 2007 Jun 18.
PubMed 17577017Curigliano 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.
PubMed 22997448Garcia 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.
PubMed 21233190Garcia 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.
PubMed 25311927Slomka 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.
PubMed 24948149
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04629937
- Acronym / sponsor ID
- STARGAC / CHRO 2020-20
- Conditions
- Cardiac Function
- Keywords
- SPECT, gated tomographic radionuclide angiography, Multipurpose CZT camera, left ventricle ejection fraction, Radionuclide angiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Study start
- 30 Dec 2020 (actual)
- Primary completion
- 6 Aug 2021 (actual)
- Study completion
- 6 Aug 2021 (actual)
- First posted
- 16 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patients will undergo SPECT acquisitions with both multipurpose CZT camera and cardiac dedicated CZT camera.
| Arm | Type | Receives |
|---|---|---|
| SPECT acquisitions | Experimental | Other: SPECT acquisitionsAll patients will undergo SPECT acquisitions with both multipurpose CZT camera and cardiac dedicated CZT camera. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients referred to our Nuclear Medicine department for evaluation of cardiac function.
Key exclusion criteria (8 listed)
- Patients treated with chemotherapy within 12 days.
- Under 18 years old patients.
- Pregnant women or at risk of pregnancy.
- Breast feeding.
- Painful patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPECT acquisitionsAll patients will undergo SPECT acquisitions with both multipurpose CZT camera and cardiac dedicated CZT camera. | Other | SPECT acquisitions |
Primary outcome
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).
1 secondary outcome
Assessment of left and ventricular volumes and ejection fraction with attenuation correction.
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2022.
- Background: PubMed 30207593Bray 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.
- Background: PubMed 17577017Carver 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. doi: 10.1200/JCO.2007.10.9777. Epub 2007 Jun 18.
- Background: PubMed 22997448Curigliano 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.
- Background: PubMed 21233190Garcia 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.
- Background: PubMed 25311927Garcia 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.
- Background: PubMed 24948149Slomka 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frédérique THIBAULT, Dr principal investigator
CHR d'Orléans
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPECT acquisitions in people with Cardiac Function, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of left and right ventricular volumes and ejection fraction. (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04629937, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2022.