Clinical Trials Directory

Trials / Terminated

TerminatedNCT04934046

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

Clinical Evaluation of a New Multipurpose Whole-body CZT Camera in DaTSCAN Brain Scintigraphy: a Head-to-head Comparison With a Conventional System.

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
14 (actual)
Sponsor
Centre Hospitalier Régional d'Orléans · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
OTHERAdditional acquisitionAdditional SPECT acquisition (30min added time approximately), with no added radiation

Timeline

Start date
2021-04-02
Primary completion
2022-12-02
Completion
2022-12-02
First posted
2021-06-22
Last updated
2024-01-10

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT04934046. Inclusion in this directory is not an endorsement.