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

Sponsor
Lille Catholic University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03414021
Collaborator
(none)
250
2
60
125
2.1

Study Details

Study Description

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 Phase
  • Diagnostic Test: SPECT-CT Scan

Study Design

Study Type:
Observational
Anticipated 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
Actual Study Start Date :
Jan 31, 2018
Anticipated Primary Completion Date :
Jan 30, 2023
Anticipated Study Completion Date :
Jan 30, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. SUVspect [5 years]

    Pathological threshold (SUVspect) for every type of scintigraphy

Secondary Outcome Measures

  1. Matrix size [5 years]

    Optimize the reconstruction parameters of the images

  2. duration of image acquisition [5 years]

    Optimize the reconstruction parameters of the images

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Humanitep Lomme Hauts De France France 59462
2 Hopital Privé Le Bois Lille Hauts-de-France France 59000

Sponsors and Collaborators

  • Lille Catholic University

Investigators

  • Principal Investigator: Tanguy Blaire, MD, GIE HUMANITEP, GHICL
  • Principal Investigator: Alban Baillez, MD, GIE HUMANITEP, GHICL

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lille Catholic University
ClinicalTrials.gov Identifier:
NCT03414021
Other Study ID Numbers:
  • OBS-0030
First Posted:
Jan 29, 2018
Last Update Posted:
Aug 28, 2019
Last Verified:
Aug 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 28, 2019