Evaluation of an Accelerated Body-whole Bone CT Procedure With the CZT(Cadmium-Zinc-Telluride) "VERITON-CT ™" Camera

NCT04157166 | Completed

• 1 other identifier: Central HNF
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of the OSS study is to evaluate a procedure involving a single full body SPECT/CT (Single photon emission computed tomography coupled with a computerized tomography) 3D recording with a new semiconductor camera,his name is VERITON-CT ™ (Spectrum Dynamics Medical). This recording can be done in less than 25 minutes due to an original system of CZT (Cadmium-Zinc-Telluride) detectors allowing to increase the quality of the images and especially, to multiply by a factor 2 to 3 the detection sensitivity. This camera is also equipped with a scanner capable of obtaining a body-to-integer recording with a low level of irradiation (≤ 2 mSv)

Conditions

Bone Metastases

Keywords

Bone scan; solid state gama camera CZT-based detector; hybrid SPECT/CT imaging; bone metastasis

Outcome Measures

Primary Outcomes (1)

• concordance between the two procedures

  Concordance between the 2 procedures of the importance of scintigraphic abnormalities evoking a neoplastic process and which will be classified into 3 categories (these categories may correspond to different medical and therapeutic care) : 1) absence of any suspicious focus, 2) 1 or 2 metastases 3) more than 2 metastases

  half hour

Secondary Outcomes (1)

• concordance between the two procedures 3D

  half hour

Study Arms (2)

group 1 in pair week

EXPERIMENTAL

In pair week, patients will be included in group1:a conventional recording with SPECT/CT will be realized in first time

Diagnostic Test: Group 1 to record a 25 minutes whole body 3D in camera VERITON-CT ™ after scintigraphy + SPECT/CT in camera d'Anger

group 2 in odd week

EXPERIMENTAL

In odd week, patients will be included in group2: a 25 minutes recording 3D in camera VERITON-CT ™ will be realized in first time

Diagnostic Test: Group 1 to record a 25 minutes whole body 3D in camera VERITON-CT ™ after scintigraphy + SPECT/CT in camera d'Anger

Interventions

Group 1 to record a 25 minutes whole body 3D in camera VERITON-CT ™ after scintigraphy + SPECT/CT in camera d'Anger DIAGNOSTIC_TEST

The procedure of recording of 25 minutes in camera VERITON-CT ™ including the registration whole body 3D coupled to a scanner low dose (CT) will be added to conventional recording followed by complementary images SPECT/CT in the second time for the group 1 and in the first time for the group 2

Also known as: Group 2 to record a 25 minutes whole body 3D in camera VERITON-CT ™ before scintigraphy + SPECT/CT in camera d'Anger

group 1 in pair week; group 2 in odd week

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient having read and understood the information document and having signed the consent.
• Patient referred for bone scintigraphy to detect possible metastatic or primary neoplastic lesions (known neoplastic antecedent), or for assessment and / or follow-up of known neoplastic bone lesions
• Patient agreeing to perform the additional 25 minutes of recording with the VERITON-CT ™ camera.
• Patient being affiliated to a social security scheme

You may not qualify if:

• A woman who is pregnant or of childbearing age and without suitable contraceptive means
• No signature of the informed consent form by the patient.
• Unstable medical condition and / or inability to remain still in the supine position during the recordings
• Person with a known allergy to one of the components of the radiotracer (TECHNESCAN HDP).
• Person deprived of liberty by a judicial or administrative decision.
• Major person subject to a legal protection measure (guardianship, curatorship, safeguard of justice).
• Major person unable to express consent.

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead
• GIE NANCYCLOTEP: collaborator

Study Sites (2)

Service de Médecine Nucléaire - CHRU de Nancy-Brabois

Vandœuvre-lès-Nancy, 54511, France

Location

Veronique Roch

Vandœuvre-lès-Nancy, 54511, France

Location

MeSH Terms

Interventions

Single Photon Emission Computed Tomography Computed Tomography

Intervention Hierarchy (Ancestors)

Tomography, Emission-Computed, Single-Photon; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Model Details: a group in which the conventional recording followed by complementary images in planar or SPECT, will be realized in first intention and the procedure of recording of 25 minutes in camera VERITON-CT ™ including the registration whole body 3D coupled to a scanner low dose (CT), will be performed just before and, * another group in which these recordings will be made in the reverse order

Study Record Dates

• First Submitted: November 6, 2019
• First Posted: November 8, 2019
• Study Start: February 4, 2020
• Primary Completion: July 4, 2022
• Study Completion: March 2, 2023
• Last Updated: June 25, 2026

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)