Bone MetastasesOSSNCT04157166

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

A study testing Group 1 to record a 25 minutes whole body 3D in camera VERITON-CT ™ after scintigraphy + SPECT/CT in camera d'Anger in people with Bone Metastases, run by Central Hospital, Nancy, France at 2 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Bone Metastases
What is being tested?: Group 1 to record a 25 minutes whole body 3D in camera VERITON-CT ™ after scintigraphy + SPECT/CT in camera d'Anger
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 146 participants
Where: 2 sitesFrance
Study dates: 4 Feb 2020to 2 Mar 2023
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

2 sites in 1 country.

France2 sites

Service de Médecine Nucléaire - CHRU de Nancy-Brabois
Vandœuvre-lès-Nancy, 54511
Veronique Roch
Vandœuvre-lès-Nancy, 54511

Other trials in France

About this study

Official 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.

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)

Read the 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 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.

Conditions: Bone Metastases
Being tested: Group 1 to record a 25 minutes whole body 3D in camera VERITON-CT ™ after scintigraphy + SPECT/CT in camera d'Anger
Keywords: Bone scan, solid state gama camera CZT-based detector, hybrid SPECT/CT imaging, bone metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Group 1 to record a 25 minutes whole body 3D in camera VERITON-CT ™ after scintigraphy + SPECT/CT in camera d'AngerDiagnostic test
Also called Group 2 to record a 25 minutes whole body 3D in camera VERITON-CT ™ before scintigraphy + SPECT/CT in camera d'Anger
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

Study groups in NCT04157166
Study group	Role	What they receive
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 Receives: 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 Receives: Diagnostic Test: Group 1 to record a 25 minutes whole body 3D in camera VERITON-CT ™ after scintigraphy + SPECT/CT in camera d'Anger

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: half hour

Secondary outcomes (1)

concordance between the two procedures 3D
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
Measured: half hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Feb 20202 Mar 2023

First posted8 Nov 2019
Study start4 Feb 2020
Primary completion4 Jul 2022
Study completion2 Mar 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Bone MetastasesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Crossover
Model description: 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
Masking: None (open label)
Enrolment: 146 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04157166
Sponsor's protocol ID: Central HNF
Acronym: OSS
Status last verified: Jun 2024
First submitted: 6 Nov 2019
Last updated: 25 Jun 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
SFRT and SCART in Radiotherapy for Bone Metastases With Soft Tissue
Bone Metastases in Subjects With Advanced Cancer
Enrolling by invitationPhase 4
LMWH vs Aspirin for VTE Prophylaxis in Orthopaedic Oncology
Sarcoma, Soft Tissue Sarcoma
RecruitingPhase 2
Prophylactic Radiotherapy to Prevent Bone Complications in Patients With Metastatic Solid Cancers
Bone Metastases, Metastatic Solid Tumor
RecruitingPhase 1/2
Trial of 225Ac-DOTATATE (RYZ101) in Subjects With ER+, HER2-negative Unresectable or Metastatic Breast Cancer Expressing SSTRs.
Metastatic Breast Cancer, HER2-negative Breast Cancer
RecruitingObservational study
Registry for Bone Metastases
Bone Metastases

All Bone Metastases trials