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Completed

NCT Number: NCT04157166

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

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)

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de Médecine Nucléaire - CHRU de Nancy-Brabois, Vandœuvre-lès-Nancy, France

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About this study

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 University Regional Hospital Center (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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 agreeing to perform the additional 25 minutes of recording with the VERITON-CT ™ camera.
  • 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.

Treatment and study plan

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

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

Primary outcomes

  1. concordance between the two procedures

    Time frame: half hour

    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

Secondary outcomes

  1. concordance between the two procedures 3D

    Time frame: half hour

    Concordance between the 2 procedures 3D of a same region 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

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Collaborators

  • GIE NANCYCLOTEP

Registry information

Official study title

Evaluation of an Accelerated Body-whole Bone CT Procedure With the CZT(Cadmium-Zinc-Telluride) "VERITON-CT ™" Camera: a Comparison With the Conventional Full-body 2D Recording Procedure With or Without Complementary Tomoscintigraphy.

Acronym: OSS

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Nov 8, 2019
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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