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RecruitingNCT03414021GAMMA-CAMUpdated Mar 26, 2024

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

An observational study in Thyroid Diseases, Heart Diseases and Bone Diseases, sponsored by Lille Catholic University. Recruiting at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-26.

Sponsored by Lille Catholic University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
250
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

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

Keywords

  • Nuclear Medicine
  • SPECT-CT Scan
  • gamma-camera with semiconductor
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Refusal to participate
  • Patient under guardianship
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
250 participants (estimated)
Patient registry
No

Groups and cohorts

  • Thyroid Diseases

    SPECT-CT Scan

    Diagnostic Test: SPECT-CT Scan

  • Heart Diseases

    SPECT-CT Scan

    Diagnostic Test: SPECT-CT Scan

  • Bone Diseases

    SPECT-CT Scan

    Diagnostic Test: SPECT-CT Scan

  • Brain Diseases

    SPECT-CT Scan

    Diagnostic Test: SPECT-CT Scan

  • Kidney Diseases

    SPECT-CT Scan

    Diagnostic Test: SPECT-CT Scan

Interventions

  • Diagnostic testSPECT-CT Scan

    Injection of a Tracer and SPECT-CT Scan

05

What researchers measure

Primary outcomes

  1. SUVspect

    Pathological threshold (SUVspect) for every type of scintigraphy

    Time frame: 5 years

Secondary outcomes

  1. Matrix size

    Optimize the reconstruction parameters of the images

    Time frame: 5 years

  2. duration of image acquisition

    Optimize the reconstruction parameters of the images

    Time frame: 5 years

06

Study locations

1 of 2 sites recruiting
  • Humanitep
    Lomme, Hauts De France 59462, France
    • Tanguy Blaire, MD, PhD · Contact · 03.20.00.24.14
    • Tanguy Blaire, MD, PhD · Principal investigator
    • Bailliez Alban, MD, PhD · Principal investigator
    Recruiting
  • Hopital Privé Le Bois
    Lille, Hauts-de-France 59000, France
    • Tanguy Blaire, MD, PhD · Contact · 03.20.09.92.92
    • Tanguy Blaire, MD, PhD · Principal investigator
    • Alban Bailliez, MD, PhD · Principal investigator
    Not yet recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03414021
Lead sponsor
Lille Catholic University
Responsible party
Sponsor
First posted
Jan 29, 2018
Start date
Jan 31, 2018
Primary completion
Dec 30, 2025 (estimated)
Completion
Dec 30, 2025 (estimated)
Last update
Mar 26, 2024

Study contacts

Marie Paule Lebitasy, MD
Contact
Lebitasy.Marie-Paule@ghicl.net
03 20 22 57 41 ext. +33
Williams VanDenBerghe
Contact
VanDenBerghe.Williams@ghicl.net
03 20 22 57 31
Tanguy Blaire, MD
principal investigator · GIE HUMANITEP, GHICL
Alban Baillez, MD
principal investigator · GIE HUMANITEP, GHICL

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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