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Evaluation of a Semiconductor Camera for the DaTSCAN™ Exam (VERIDAT)

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
DaTSCAN SPECT/CT in VERITON-CT camera
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Parkinson Disease focused on measuring Parkinson Disease, DaTSCAN™ SPECT/CT scintigraphy, Semiconductor CZT camera "with large field"

Eligibility Criteria

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

Inclusion Criteria:

  • all patients over 18 years sent to Datscan SPECT/CT
  • patients understanding and having signed the informed consent form.
  • without contraindication to have the scintigraphy
  • patient subject to a medical benefits scheme

Exclusion Criteria:

  • known allergy to the one of the components of Datscan
  • pregnant, parturient or breastfeeding woman
  • major person under legal protection (any form of public guardianship)
  • major person unable to express consent
  • person deprived of liberty due to judicial or administrative decision.

Sites / Locations

  • CHRU of Nancy

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

all included patients will have the same procedure

Arm Description

After the conventional DaTSCAN SPECT/CT exam in conventional camera, all patients included will have two recordings of DaTSCAN SPECT/CT in semiconductor CZT (cadmium zinc telluride) camera; one focused on the striatum and the other focused on the total brain

Outcomes

Primary Outcome Measures

Degree of concordance (Kappa) of the exams results of different records
comparison between the exam results (positive diagnosis of Parkinson disease or Lewy bodies dementia versus differential diagnosis) in conventional camera and the one obtained with the VERITON-CT in striatum focus mode

Secondary Outcome Measures

Degree of concordance (Kappa) of the exams results of different recordings
comparison between the exam results (positive diagnosis of Parkinson disease or Lewy bodies dementia versus differential diagnosis) in conventional camera and the one obtained with the VERITON-CT in brain focus mode

Full Information

First Posted
June 6, 2019
Last Updated
August 23, 2022
Sponsor
Central Hospital, Nancy, France
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1. Study Identification

Unique Protocol Identification Number
NCT03980418
Brief Title
Evaluation of a Semiconductor Camera for the DaTSCAN™ Exam
Acronym
VERIDAT
Official Title
Comparative Study of DaTSCAN ™ Cerebral SPECT Recorded by Conventional Anger Cameras and Semiconductor Camera (VERITON-CT ™)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
September 5, 2019 (Actual)
Primary Completion Date
September 3, 2020 (Actual)
Study Completion Date
September 3, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central Hospital, Nancy, France

4. Oversight

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

5. Study Description

Brief Summary
The semiconductor (cadmium-zinc-telluride, CZT) cameras significantly increase detection sensitivity in Single Photon Emission Computer Tomoscintigraphy (SPECT)(1) . The clinical routine applications of these cameras are today mainly limited to myocardial tomoscintigraphy with CZT dedicated cameras. Several studies whose one was done in Hospital of Nancy, made it possible to demonstrate a good diagnosis agreement between conventional cameras and semiconductor cameras in this indication, with better image quality obtained with semiconductor cameras (2). Today, so-called "wide field" semiconductor cameras are available in the clinic and allow for any type of SPECT examination. A comparative study between conventional and semiconductor cameras has been conducted for bone scintigraphy, and shows diagnostic superiority with this new type of camera (3). In addition, the new VERITON-CT ™ (Spectrum Dynamics Medical) camera has 12 mobile CZT-based detectors positioned around the patient allowing tomographic acquisitions and focusing the acquisition on the organ studied. This camera has a sensitivity of detection higher than that of conventional cameras and thus reduces the activity injected into the patient and / or the recording time. To date, no study has compared the two types of cameras in nuclear neurology and in particular, for the SPECT DaTSCAN ™ imaging of the pre-synaptic dopaminergic pathway. DaTSCAN ™ exam is used in clinical routine: for the diagnosis of Parkinson's disease or related diseases when in doubt with an essential tremor (4) or if suspicion of Lewy body disease, if in doubt with Alzheimer's disease (5). If the interpretation of DaTSCAN ™ exam is first visual, the quantification may increase accuracy diagnosis (6). Also, the database creation specific to each type of camera is recommended(7). The purpose of this study is to compare the diagnostically relevant informations and the quantitative analysis provided by the DaTSCAN™ SPECT, recorded on the conventional camera and recorded on the semiconductor camera VERITON-CT™
Detailed Description
The clinical study is monocentric, interventional, non randomized, with minimal risk and constraints. All patients going to the nuclear medicine department for a DaTSCAN exam will be able to participate in this study if they understood study informations given by the physician and if they signed the inform consent. In first, patients will have a DaTSCAN™ SPECT on a conventional camera and after, they will have DaTSCAN™ SPECT on VERITON-CT™ camera with two records: one in focus striatum mode and the second in focus brain mode. The attenuation correction will be made with the computer tomography (CT) recorded at the same time as the SPECT (SPECT/CT)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson Disease, DaTSCAN™ SPECT/CT scintigraphy, Semiconductor CZT camera "with large field"

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
all included patients will have the same procedure
Arm Type
Experimental
Arm Description
After the conventional DaTSCAN SPECT/CT exam in conventional camera, all patients included will have two recordings of DaTSCAN SPECT/CT in semiconductor CZT (cadmium zinc telluride) camera; one focused on the striatum and the other focused on the total brain
Intervention Type
Procedure
Intervention Name(s)
DaTSCAN SPECT/CT in VERITON-CT camera
Intervention Description
the intervention is based on two recordings in camera VERITON-CT ; the first, in focus striatum mode and the second in brain focus mode
Primary Outcome Measure Information:
Title
Degree of concordance (Kappa) of the exams results of different records
Description
comparison between the exam results (positive diagnosis of Parkinson disease or Lewy bodies dementia versus differential diagnosis) in conventional camera and the one obtained with the VERITON-CT in striatum focus mode
Time Frame
16 months
Secondary Outcome Measure Information:
Title
Degree of concordance (Kappa) of the exams results of different recordings
Description
comparison between the exam results (positive diagnosis of Parkinson disease or Lewy bodies dementia versus differential diagnosis) in conventional camera and the one obtained with the VERITON-CT in brain focus mode
Time Frame
16 months
Other Pre-specified Outcome Measures:
Title
Degree of concordance (Kappa) of the exams results of different recordings
Description
comparison between the exam results (positive diagnosis of Parkinson disease versus differential diagnosis) in conventional camera and the one obtained with the VERITON-CT in striatum focus mode
Time Frame
16 months
Title
Degree of concordance (Kappa) of the exams results of different recordings
Description
comparison between the exam results (positive diagnosis of Lewy bodies dementia versus differential diagnosis) in conventional camera and the one obtained with the VERITON-CT in striatum focus mode
Time Frame
16 months after the first enrollment
Title
ratios of uptake obtained with conventional camera and on the striatum focus record with VERITON-CT
Description
the uptake ratios are:caudate nuclei/occipital cortex, putamen/occipital cortex, to the right and caudate nuclei/medium cingulate cortex, putamen/medium cingulate cortex to left, obtained with conventional camera and on the striatum focus record with VERITON-CT camera
Time Frame
immediately after SPECT-CT exam
Title
quality scores of images from conventional camera and from VERITON (striatum)
Description
0= very bad quality and impossible to do a diagnosis, 1=bad quality and difficult diagnosis, 2= medium quality, 3 = good quality and 4= excellent quality
Time Frame
immediately after SPECT-CT exam
Title
recording activity in striatal area for the images from conventional camera and from VERITON (striatum)
Description
recorded activities will be reported by injected MBq for the images obtained with the conventional camera and with VERITON striatum focus record
Time Frame
immediately after SPECT-CT exams
Title
score of diagnosis agreement for the images interpretation by 3 physicians
Description
The agreement will be between conventional record and striatum focus record with VERITON camera
Time Frame
18 months
Title
uptake ratios on the conventional record and on the focus brain record with VERITON
Description
the uptake ratios are:caudate nuclei/occipital cortex, putamen/occipital cortex, to the right and caudate nuclei/medium cingulate cortex, putamen/medium cingulate cortex to left, obtained with conventional camera and on the brain focus record with VERITON-CT camera
Time Frame
after each SPECT/CT exams
Title
quality scores of images from conventional camera and from VERITON (brain)
Description
0= very bad quality and impossible to do a diagnosis, 1=bad quality and difficult diagnosis, 2= medium quality, 3 = good quality and 4= excellent quality
Time Frame
immediately after SPECT-CT exams
Title
recording activity in striatal area for the images from conventional camera and from VERITON (brain)
Description
recorded activities will be reported by injected MegaBecquerel (MBq) for the images obtained with the conventional camera and with VERITON brain focus record
Time Frame
18 months
Title
diagnosis agreement for the interpretation by 3 physicians between conventional and VERITON (brain)
Description
The agreement will be between conventional record and brain focus record with VERITON camera
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: all patients over 18 years sent to Datscan SPECT/CT patients understanding and having signed the informed consent form. without contraindication to have the scintigraphy patient subject to a medical benefits scheme Exclusion Criteria: known allergy to the one of the components of Datscan pregnant, parturient or breastfeeding woman major person under legal protection (any form of public guardianship) major person unable to express consent person deprived of liberty due to judicial or administrative decision.
Facility Information:
Facility Name
CHRU of Nancy
City
Vandoeuvre les Nancy cedex
ZIP/Postal Code
54511
Country
France

12. IPD Sharing Statement

Learn more about this trial

Evaluation of a Semiconductor Camera for the DaTSCAN™ Exam

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