Clinical trial NCT03980418: Evaluation of a Semiconductor Camera for the DaTSCAN™ Exam
Official title: Comparative Study of DaTSCAN ™ Cerebral SPECT Recorded by Conventional Anger Cameras and Semiconductor Camera (VERITON-CT ™)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson Disease
DaTSCAN™ SPECT/CT scintigraphy
Semiconductor CZT camera "with large field"
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2019-06-10
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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:

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™

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)

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.

Primary outcomes:
measure: Degree of concordance (Kappa) of the exams results of different records
timeFrame: 16 months
Secondary outcomes:
measure: Degree of concordance (Kappa) of the exams results of different recordings
timeFrame: 16 months
Other outcomes:
measure: Degree of concordance (Kappa) of the exams results of different recordings
timeFrame: 16 months
measure: Degree of concordance (Kappa) of the exams results of different recordings
timeFrame: 16 months after the first enrollment
measure: ratios of uptake obtained with conventional camera and on the striatum focus record with VERITON-CT
timeFrame: immediately after SPECT-CT exam
measure: quality scores of images from conventional camera and from VERITON (striatum)
timeFrame: immediately after SPECT-CT exam
measure: recording activity in striatal area for the images from conventional camera and from VERITON (striatum)
timeFrame: immediately after SPECT-CT exams
measure: score of diagnosis agreement for the images interpretation by 3 physicians
timeFrame: 18 months
measure: uptake ratios on the conventional record and on the focus brain record with VERITON
timeFrame: after each SPECT/CT exams
measure: quality scores of images from conventional camera and from VERITON (brain)
timeFrame: immediately after SPECT-CT exams
measure: recording activity in striatal area for the images from conventional camera and from VERITON (brain)
timeFrame: 18 months
measure: diagnosis agreement for the interpretation by 3 physicians between conventional and VERITON (brain)
timeFrame: 18 months
Locations:
city: Vandoeuvre les Nancy cedex
country: France
facility: CHRU of Nancy
Study officials:
References: