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

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Diseases; Brain Diseases; Kidney Diseases; Thyroid Diseases; Bone Diseases
• Intervention / Treatment: Diagnostic test: SPECT-CT Scan

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Marie Paule Lebitasy, MD; Phone Number: +33 03 20 22 57 41; Email: Lebitasy.Marie-Paule@ghicl.net
• Study Contact Backup: Name: Williams VanDenBerghe; Phone Number: 03 20 22 57 31; Email: VanDenBerghe.Williams@ghicl.net

Study Locations

• France
  • Hauts De France
    • Lomme, Hauts De France, France, 59462
      • Recruiting
      • Humanitep
      • Contact: Tanguy Blaire, MD, PhD; Phone Number: +33 03.20.00.24.14
      • Principal Investigator: Tanguy Blaire, MD, PhD
      • Principal Investigator: Bailliez Alban, MD, PhD
  • Hauts-de-France
    • Lille, Hauts-de-France, France, 59000
      • Not yet recruiting
      • Hôpital Privé Le Bois
      • Principal Investigator: Tanguy Blaire, MD, PhD
      • Contact: Tanguy Blaire, MD, PhD; Phone Number: +33 03.20.09.92.92
      • Principal Investigator: Alban Bailliez, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

5

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SUVspect	Pathological threshold (SUVspect) for every type of scintigraphy	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Matrix size	Optimize the reconstruction parameters of the images	5 years
duration of image acquisition	Optimize the reconstruction parameters of the images	5 years

Collaborators and Investigators

• Sponsor: Lille Catholic University
• Investigators: Principal Investigator: Tanguy Blaire, MD, GIE HUMANITEP, GHICL; Principal Investigator: Alban Baillez, MD, GIE HUMANITEP, GHICL

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2018
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: January 23, 2018
• First Submitted That Met QC Criteria: January 23, 2018
• First Posted (Actual): January 29, 2018

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 25, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Nuclear Medicine; SPECT-CT Scan; gamma-camera with semiconductor
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Central Nervous System Diseases; Nervous System Diseases; Urologic Diseases; Endocrine System Diseases; Musculoskeletal Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Heart Diseases; Kidney Diseases; Thyroid Diseases; Brain Diseases; Bone Diseases
• Other Study ID Numbers: OBS-0030

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No