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Interest of the SPECT-CT Scan SUVspect in the New Generation of Gamma-cameras With Semiconductor (GAMMA-CAM)

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ClinicalTrials.gov Identifier: NCT03414021
Recruitment Status : Recruiting
First Posted : January 29, 2018
Last Update Posted : January 29, 2018
Sponsor:
Information provided by (Responsible Party):
Lille Catholic University

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.


Condition or disease Intervention/treatment
Thyroid Diseases Heart Diseases Bone Diseases Brain Diseases Kidney Diseases Diagnostic Test: SPECT-CT Scan

Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Estimated Study Start Date : January 31, 2018
Estimated Primary Completion Date : January 30, 2023
Estimated Study Completion Date : January 30, 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Thyroid Diseases
SPECT-CT Scan
Diagnostic Test: SPECT-CT Scan
Injection of a Tracer and SPECT-CT Scan

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

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

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

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




Primary Outcome Measures :
  1. SUVspect [ Time Frame: 5 years ]
    Pathological threshold (SUVspect) for every type of scintigraphy


Secondary Outcome Measures :
  1. Matrix size [ Time Frame: 5 years ]
    Optimize the reconstruction parameters of the images

  2. duration of image acquisition [ Time Frame: 5 years ]
    Optimize the reconstruction parameters of the images



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Every patient referred to our departments of nuclear medicine for a nuclear médicine exploration
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03414021


Contacts
Contact: Amélie Lansiaux, MD, PhD 03 20 22 52 69 ext +33 lansiaux.amelie@ghicl.net
Contact: Jean-Jacques Vitagliano, PhD 03 20 22 57 51 vitagliano.jean-jacques@ghicl.net

Locations
France
Humanitep Recruiting
Lomme, Hauts De France, France, 59462
Contact: Tanguy Blaire, MD, PhD    03.20.00.24.14 ext +33      
Principal Investigator: Tanguy Blaire, MD, PhD         
Principal Investigator: Bailliez Alban, MD, PhD         
Hopital Privé Le Bois Not yet recruiting
Lille, Hauts-de-France, France, 59000
Contact: Tanguy Blaire, MD, PhD    03.20.09.92.92 ext +33      
Principal Investigator: Tanguy Blaire, MD, PhD         
Principal Investigator: Alban Bailliez, MD, PhD         
Sponsors and Collaborators
Lille Catholic University
Investigators
Principal Investigator: Tanguy Blaire, MD GIE HUMANITEP, GHICL
Principal Investigator: Alban Baillez, MD GIE HUMANITEP, GHICL

Responsible Party: Lille Catholic University
ClinicalTrials.gov Identifier: NCT03414021     History of Changes
Other Study ID Numbers: OBS-0030
First Posted: January 29, 2018    Key Record Dates
Last Update Posted: January 29, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lille Catholic University:
Nuclear Medicine
SPECT-CT Scan
gamma-camera with semiconductor

Additional relevant MeSH terms:
Brain Diseases
Kidney Diseases
Heart Diseases
Bone Diseases
Thyroid Diseases
Urologic Diseases
Cardiovascular Diseases
Musculoskeletal Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases