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

NCT04157166 | Unknown

• 1 other identifier: Central HNF
• Study Type: interventional
• Target: 146
• Locations: 0 countries
• Sites: N/A

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)

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

OTHER

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

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

group 2 in odd week

OTHER

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

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

Interventions

to record a whole body 3D of 25 minutes in camera VERITON-CT ™ 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 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 acceptant de réaliser les 25 minutes d'enregistrement supplémentaire avec la caméra VERITON-CT™.
• 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

Central Study Contacts

PERRIN PM Mathieu, MD

CONTACT

+33 383 15 39 11; M.PERRIN2@chru-nancy.fr

ROCH RV Véronique, MSc

CONTACT

+33 383 15 42 76; v.roch@chru-nancy.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: a group in which the conventional recording followed by complementary images in planar or TEMP, 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: January 20, 2020
• Primary Completion: January 21, 2021
• Study Completion: January 20, 2022
• Last Updated: November 8, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share