Evaluation of an Accelerated Body-whole Bone CT Procedure With the CZT "VERITON-CT ™" Camera

NCT ID: NCT04157166

Last Updated: 2019-11-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 146 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-20
• Study Completion Date: 2022-01-20

Brief Summary

The purpose of the OSS study is to evaluate a procedure involving a single full body TEMP / TDM 3D recording with a new semiconductor camera, the 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)

Detailed Description

Interventional study (RIPH-2), monocentric and randomized in open. All patients routinely referred for bone scans as part of a search for primary or metastatic neoplastic bone lesions (known neoplastic history) will be offered to participate in the study by the doctors of the nuclear medicine department of the CHRU from Nancy.

The capture of tracers used for bone scintigraphy (technetium-99m-labeled bisphosphonates) is highly dependent on bone remodeling, osteoblast activity and tissue perfusion . This is why bone scintigraphy is a sensitive examination, capable of detecting anomalies before their radiological translation . 3-dimensional (3D) recordings called SPECT detect bone metastases with a sensitivity equivalent to that of MRI .

These SPECT are most often produced by hybrid systems, in combination with X-ray scanner (CT) recordings, which makes it possible to correct certain imperfections in the quantification of the measured activities (attenuation, diffusion, partial volume) and also, to complete the characterization of lesions.

Bone diseases, which are often diffuse, frequently require two-dimensional (2D) whole body recordings, but these are unfortunately less informative and less sensitive than 3D recordings. This is why complementary focused SPECT / CT images are recommended for areas that are difficult to explore, especially the pelvis and spine, and when neoplastic lesions are suspected. This registration procedure is long (about 40 minutes), difficult for some patients to support, and does not offer an optimal 3D analysis of the entire skeleton.

Conditions

Bone Metastases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

group 1 in pair week

In pair week, patients will inclued in group1: the conventional recording followed by complementary images SPECT/CT, will be realized in first intention and the procedure of recording in camera VERITON will be recorderd in second intention

Group Type: OTHER

to record a whole body 3D of 25 minutes in camera VERITON-CT ™

Intervention Type: 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

group 2 in odd week

in odd week, patients will inclued in group2: the procedure of recording of 25 minutes in camera VERITON-CT ™, will be realized in first intention and the procedure of conventional recording followed by complementary images SPECT/CT will be recorded in second intention

Group Type: OTHER

to record a whole body 3D of 25 minutes in camera VERITON-CT ™

Intervention Type: 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

Interventions

to record a whole body 3D of 25 minutes in camera VERITON-CT ™

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 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 acceptant de réaliser les 25 minutes d'enregistrement supplémentaire avec la caméra VERITON-CT™.
• Patient being affiliated to a social security scheme

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GIE NANCYCLOTEP

OTHER

Sponsor Role: collaborator

Central Hospital, Nancy, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

PERRIN PM Mathieu, MD

Role: CONTACT

M.PERRIN2@chru-nancy.fr

+33 383 15 39 11

ROCH RV Véronique, MSc

Role: CONTACT

v.roch@chru-nancy.fr

+33 383 15 42 76

Other Identifiers

Central HNF

Identifier Type: -

Identifier Source: org_study_id