Tracking Information

First Submitted Date ^ICMJE

June 6, 2019

First Posted Date ^ICMJE

June 10, 2019

Last Update Posted Date

January 27, 2021

Actual Study Start Date ^ICMJE

September 5, 2019

Actual Primary Completion Date

September 3, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Degree of concordance (Kappa) of the exams results of different records [ Time Frame: 16 months ]

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

Original Primary Outcome Measures ^ICMJE

Degree of concordance (Kappa) of the exams results of different records [ Time Frame: 5 minutes/ patient ]

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

Change History

Current Secondary Outcome Measures ^ICMJE

Degree of concordance (Kappa) of the exams results of different recordings [ Time Frame: 16 months ]

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

Original Secondary Outcome Measures ^ICMJE

Degree of concordance (Kappa) of the exams results of different records [ Time Frame: 5 minutes/patient ]

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

Current Other Pre-specified Outcome Measures

Degree of concordance (Kappa) of the exams results of different recordings [ Time Frame: 16 months ]
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
Degree of concordance (Kappa) of the exams results of different recordings [ Time Frame: 16 months after the first enrollment ]
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
ratios of uptake obtained with conventional camera and on the striatum focus record with VERITON-CT [ Time Frame: immediately after SPECT-CT exam ]
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
quality scores of images from conventional camera and from VERITON (striatum) [ Time Frame: immediately after SPECT-CT exam ]
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
recording activity in striatal area for the images from conventional camera and from VERITON (striatum) [ Time Frame: immediately after SPECT-CT exams ]
recorded activities will be reported by injected MBq for the images obtained with the conventional camera and with VERITON striatum focus record
score of diagnosis agreement for the images interpretation by 3 physicians [ Time Frame: 18 months ]
The agreement will be between conventional record and striatum focus record with VERITON camera
uptake ratios on the conventional record and on the focus brain record with VERITON [ Time Frame: after each SPECT/CT exams ]
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
quality scores of images from conventional camera and from VERITON (brain) [ Time Frame: immediately after SPECT-CT exams ]
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
recording activity in striatal area for the images from conventional camera and from VERITON (brain) [ Time Frame: 18 months ]
recorded activities will be reported by injected MegaBecquerel (MBq) for the images obtained with the conventional camera and with VERITON brain focus record
diagnosis agreement for the interpretation by 3 physicians between conventional and VERITON (brain) [ Time Frame: 18 months ]
The agreement will be between conventional record and brain focus record with VERITON camera

Original Other Pre-specified Outcome Measures

Degree of concordance (Kappa) of the exams results of different records [ Time Frame: 5 minutes/patient ]
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
Degree of concordance (Kappa) of the exams results of different records [ Time Frame: 5 minutes/patient ]
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
ratios of uptake obtained with conventional camera and on the striatum focus record with VERITON-CT [ Time Frame: 10 minutes/patient ]
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
quality scores of images from conventional camera and from VERITON (striatum) [ Time Frame: 5 minutes per patient ]
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
recording activity in striatale area for the images from conventional camera and from VERITON (striatum) [ Time Frame: 10 minutes/patient ]
recorded activities will be reported by injected MBq for the images obtained with the conventional camera and with VERITON striatum focus record
score of diagnosis agreement for the images interpretation by 3 physicians [ Time Frame: two hours ]
The agreement will be between conventional record and striatum focus record with VERITON camera
uptake ratios on the conventional record and on the focus brain record with VERITON [ Time Frame: 10 minutes/patient ]
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
quality scores of images from conventional camera and from VERITON (brain) [ Time Frame: 5 minutes per patient ]
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
recording activity in striatale area for the images from conventional camera and from VERITON (brain) [ Time Frame: 10 minutes/ patient ]
recorded activities will be reported by injected MBq for the images obtained with the conventional camera and with VERITON brain focus record
diagnosis agreement for the interpretation by 3 physicians between conventional and VERITON (brain) [ Time Frame: two hours ]
The agreement will be between conventional record and brain focus record with VERITON camera

Descriptive Information

Brief Title ^ICMJE

Evaluation of a Semiconductor Camera for the DaTSCAN™ Exam

Official Title ^ICMJE

Comparative Study of DaTSCAN ™ Cerebral SPECT Recorded by Conventional Anger Cameras and Semiconductor Camera (VERITON-CT ™)

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)

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Not Applicable

Study Design ^ICMJE

Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic

Condition ^ICMJE

Parkinson Disease

Intervention ^ICMJE

Procedure: DaTSCAN SPECT/CT in VERITON-CT camera

the intervention is based on two recordings in camera VERITON-CT ; the first, in focus striatum mode and the second in brain focus mode

Study Arms ^ICMJE

Experimental: all included patients will have the same procedure

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: Procedure: DaTSCAN SPECT/CT in VERITON-CT camera

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Actual Enrollment ^ICMJE

96

Original Estimated Enrollment ^ICMJE

Same as current

Actual Study Completion Date ^ICMJE

September 3, 2020

Actual Primary Completion Date

September 3, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

No

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

France

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT03980418

Other Study ID Numbers ^ICMJE

PSS2019/VERIDAT-VERGER-VS

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

IPD Sharing Statement ^ICMJE

Not Provided

Responsible Party

Central Hospital, Nancy, France

Study Sponsor ^ICMJE

Central Hospital, Nancy, France

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

PRS Account

Central Hospital, Nancy, France

Verification Date

September 2020

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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

study details

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