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

Central Hospital, Nancy, France

Status: Completed

Conditions: Parkinson Disease

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03980418

PSS2019/VERIDAT-VERGER-VS

Details and patient eligibility

About

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™

Full 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)

Enrollment: 96 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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96 participants in 1 patient group

all included patients will have the same procedure

Experimental group

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

Treatment:

Procedure: DaTSCAN SPECT/CT in VERITON-CT camera