NCT04629937

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 16, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

December 30, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 6, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 6, 2021

Completed
Last Updated

July 18, 2022

Status Verified

July 1, 2022

Enrollment Period

7 months

First QC Date

November 10, 2020

Last Update Submit

July 15, 2022

Conditions

Cardiac Function

Keywords

SPECTgated tomographic radionuclide angiographyMultipurpose CZT cameraleft ventricle ejection fractionRadionuclide angiography

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

    Day 0

Study Arms (1)

SPECT acquisitions

EXPERIMENTAL

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

Other: SPECT acquisitions

Interventions

SPECT acquisitionsOTHER

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

SPECT acquisitions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHR d'Orleans

Orléans, 45067, France

Location

Related 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.

    PMID: 30207593BACKGROUND

  • 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. doi: 10.1200/JCO.2007.10.9777. Epub 2007 Jun 18.

    PMID: 17577017BACKGROUND

  • 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.

    PMID: 22997448BACKGROUND

  • 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.

    PMID: 21233190BACKGROUND

  • 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.

    PMID: 25311927BACKGROUND

  • 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.

    PMID: 24948149BACKGROUND

Study Officials

  • Frédérique THIBAULT, Dr

    CHR d'Orléans

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: All patients will undergo SPECT acquisitions with both multipurpose CZT camera and cardiac dedicated CZT camera.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2020

First Posted

November 16, 2020

Study Start

December 30, 2020

Primary Completion

August 6, 2021

Study Completion

August 6, 2021

Last Updated

July 18, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)