Interest of the SPECT-CT Scan SUVspect in the New Generation of Gamma-cameras With Semiconductor

Heart Diseases Clinical Trial

— GAMMA-CAM  

Official title:

Quantification in Nuclear Medicine: Interest of the in SPECT-CT Scan SUVspect in Thea New Generation of Gamma-cameras With Semiconductor. Data Collection for the Constitution of an Observatory of Scintigraphies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03414021
• Other study ID #: OBS-0030
• Status: Recruiting
• Start date: January 31, 2018
• Est. completion date: December 30, 2025

Study information

• Verified date: March 2024
• Source: Lille Catholic University
• Contact: Marie Paule Lebitasy, MD
• Phone: 03 20 22 57 41
• Email: Lebitasy.Marie-Paule[@]ghicl.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Since 2017, a revolution began in the departments of nuclear medicine, with the routine use of gamma-cameras with semiconductor. These gamma-cameras (which obtained the CE-marking in 2016), offer a technological breakthrough by providing an additional information. They allow "to quantify" for the 1st time in clinical routine conditions, the quantity of radioactivity, by means of a "SUVspect", in a volume of interest, while respecting the recommendations of best practice of the learned societies of French nuclear medicine (SFMN), European (EANM) and American (SNM), without injection of tracer nor acquisition or additional irradiation. The SUVspect is therefore an indicator of the quantity of tracer in a given volume of acquisition.

Until now, the interpretation criteria of scintigraphies are based on the homogeneity of distribution of a tracer in the explored organ (for single organs such as the heart or the thyroid, for example) or in the asymmetry of distribution of the tracer (for the double organs, such as the kidney or the joints).

This new gamma-camera allows to study the distribution of the radio-tracers in "list" mode, allowing to retrospectively reconstruct the images in various ways (for example, by modifying the size of the matrix of acquisition, the energy windows, the time of acquisition). Therefore, we can simulate and propose modifications in current procedures.

Every patient referred to our department of nuclear medicine to undergo a scintigraphy with a tracer of nuclear medicine (with a marketing authorization) can, while benefiting from an examination by this gamma-camera, to be the object of this study, and to profit from this additional information.

So, without changing the diagnosis or the usual care, we wish to take advantage of this additional information to improve the criteria of interpretation of our examinations.

This possibility being new, there is no available bibliography (our department is the 5th department of nuclear medicine in Europe to equip itself with this large field-of-view gamma-camera CZT, the DNM 670, made by General Electric), while 2961 articles speak about the SUVmax (in PET) in Pubmed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• informed adult patients referred to our department of nuclear medicine for a nuclear medicine exploration

Exclusion Criteria:

• Refusal to participate

• Patient under guardianship

Related Conditions & MeSH terms

• Bone Diseases
• Brain Diseases
• Heart Diseases
• Kidney Diseases
• Thyroid Diseases

Intervention

Diagnostic Test:
• SPECT-CT Scan
Injection of a Tracer and SPECT-CT Scan

Locations

Country	Name	City	State
France	Hopital Privé Le Bois	Lille	Hauts-de-France
France	Humanitep	Lomme	Hauts De France

Sponsors (1)

Lead Sponsor	Collaborator
Lille Catholic University

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SUVspect	Pathological threshold (SUVspect) for every type of scintigraphy	5 years
Secondary	Matrix size	Optimize the reconstruction parameters of the images	5 years
Secondary	duration of image acquisition	Optimize the reconstruction parameters of the images	5 years