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

Primary Purpose

Bone Metastases

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
to record a whole body 3D of 25 minutes in camera VERITON-CT ™
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bone Metastases focused on measuring Bone scan, solid state gama camera CZT-based detector, hybrid SPECT/CT imaging, bone metastasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    group 1 in pair week

    group 2 in odd week

    Arm Description

    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

    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

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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

    Full Information

    First Posted
    November 6, 2019
    Last Updated
    November 6, 2019
    Sponsor
    Central Hospital, Nancy, France
    Collaborators
    GIE NANCYCLOTEP
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04157166
    Brief Title
    Evaluation of an Accelerated Body-whole Bone CT Procedure With the CZT "VERITON-CT ™" Camera
    Acronym
    OSS
    Official Title
    Evaluation of an Accelerated Body-whole Bone CT Procedure With the CZT "VERITON-CT ™" Camera: a Comparison With the Conventional Full-body 2D Recording Procedure With or Without Complementary Tomoscintigraphy.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 20, 2020 (Anticipated)
    Primary Completion Date
    January 21, 2021 (Anticipated)
    Study Completion Date
    January 20, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Central Hospital, Nancy, France
    Collaborators
    GIE NANCYCLOTEP

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bone Metastases
    Keywords
    Bone scan, solid state gama camera CZT-based detector, hybrid SPECT/CT imaging, bone metastasis

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    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
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    146 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    group 1 in pair week
    Arm Type
    Other
    Arm Description
    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
    Arm Title
    group 2 in odd week
    Arm Type
    Other
    Arm Description
    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
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    to record a whole body 3D of 25 minutes in camera VERITON-CT ™
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    concordance between the two procedures
    Description
    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
    Time Frame
    half hour
    Secondary Outcome Measure Information:
    Title
    concordance between the two procedures 3D
    Description
    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
    Time Frame
    half hour

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    PERRIN PM Mathieu, MD
    Phone
    +33 383 15 39 11
    Email
    M.PERRIN2@chru-nancy.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    ROCH RV Véronique, MSc
    Phone
    +33 383 15 42 76
    Email
    v.roch@chru-nancy.fr

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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