Evaluation of Dopaminergic Denervation by DaTSCAN Brain Scintigraphy Using a New Multipurpose CZT System (STARDAT)

Centre Hospitalier Régional d'Orléans

Status: Terminated

Conditions: Parkinson Disease

Treatments: Other: Additional acquisition

Study type: Interventional

Funder types: Other

Identifiers

NCT04934046

CHRO-2020-21

Details and patient eligibility

About

DaTSCAN is an important tool in the diagnosis and clinical management of Parkinson's syndromes.

New cadmium-zinc-telluride (CZT) systems allow time and/or dose reduction. This can be interesting in DaTSCAN acquisitions as those are long-lasting, often on difficult patients.

This study will evaluate the diagnostic performances of a new 3D-ring CZT camera in DaTSCAN SPECT.

Full description

DaTSCAN is an important tool in the diagnosis and clinical management of Parkinson's syndromes, particularly for the diagnosis of Parkinson's disease or in the exploration of dementia-type neurodegenerative diseases.

The acquisition of tomoscintigraphic images is performed 3 hours after injection and lasts approximately 30 minutes on a conventional gamma camera.

Recently, the introduction of systems equipped with cadmium-zinc-telluride (CZT) technology has made it possible to reduce acquisition times and/or injected doses. Among these systems, some new 3D-ring CZT cameras allow tomoscintigraphic acquisitions to be carried out from the outset for the exploration of different organs.

Patients included in this study will be double scanned both on a conventional camera and on the new multipurpose CZT system, with CT.

The primary objective is to evaluate the diagnostic concordance between the DaTSCAN brain scintigraphy images from the new CZT SPECT/CT system and those from the conventional SPECT camera, when visually interpreted blindly by experienced observers (nuclear medicine physicians), according to a diagnostic scale.

Striatal binding ratios (SBR) will also be compared. Time reduction will also be evaluated on DaTSCAN SPECT data from the new multi-purpose CZT system.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients referred to our Nuclear Medicine department for DaTSCAN scintigraphy.

Exclusion criteria

• Under 18 years-old patients.
• Pregnant women or at risk of pregnancy.
• Breast feeding.
• Painful patients.
• Patients under guardianship.
• Patients in whom a standard examination is not feasible (agitation).

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

DaTSCAN brain scan images from the new CZT SPECT system

Experimental group

Description:

All patients will undergo additional SPECT acquisition (30min added time approximately), with no added radiation, with both new multipurpose CZT camera (StarGuide system, GE Healthcare, Haïfa, Israel) and conventional SPECT camera (Discovery 670, GE Healthcare, Haïfa, Israel)

Treatment:

Other: Additional acquisition