NCT03414021|Recruiting

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

GAMMA-CAM

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

Lille Catholic University ClinicalTrials.gov

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1 other identifier

OBS-0030

Study Type

observational

Target

250

Locations

1 country

Sites

Timeline

RegisteredJan 2018

StartedJan 2018

CompletionDec 2025

Brief 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.

Trial Health

Monitor

Trial Health Score

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

Trial has exceeded expected completion date

Enrollment

250

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach

1 country

2 active sites

Status

recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

7.9 years study duration

First Submitted

Initial submission to the registry

January 23, 2018

Completed

6 days until next milestone

First Posted

Study publicly available on registry

January 29, 2018

Completed

2 days until next milestone

Study Start

First participant enrolled

January 31, 2018

Completed

7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed

Last Updated

March 26, 2024

Status Verified

March 1, 2024

Enrollment Period

7.9 years

First QC Date

January 23, 2018

Last Update Submit

March 25, 2024

Conditions

Thyroid Diseases Heart Diseases Bone Diseases Brain Diseases Kidney Diseases

Keywords

Nuclear MedicineSPECT-CT Scangamma-camera with semiconductor

Outcome Measures

Primary Outcomes (1)

SUVspect
Pathological threshold (SUVspect) for every type of scintigraphy
5 years

Secondary Outcomes (2)

Matrix size
5 years
duration of image acquisition
5 years