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NCT Number: NCT03980418

Evaluation of a Semiconductor Camera for the DaTSCAN™ Exam

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:

1. for the diagnosis of Parkinson's disease or related diseases when in doubt with an essential tremor (4) or 2. 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™

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU of Nancy

Vandœuvre-lès-Nancy, 54511, France

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DaTSCAN SPECT/CT in VERITON-CT camera

Procedure

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 outcomes

  1. 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

Secondary outcomes

  1. 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

Other outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

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

Acronym: VERIDAT

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 10, 2019
Registry last updated
Aug 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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