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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04934046
Acronym
STARDAT
Enrollment
14
Registered
2021-06-22
Start date
2021-04-02
Completion date
2022-12-02
Last updated
2024-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

Keywords

DaTSCAN, Multipurpose CZT camera

Brief 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.

Interventions

OTHERAdditional acquisition

Additional SPECT acquisition (30min added time approximately), with no added radiation

Sponsors

Centre Hospitalier Régional d'Orléans
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Intervention model description

All patients will undergo SPECT acquisitions with both new multipurpose CZT camera and conventional SPECT camera.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Change in the visual Benamer Scale between new and conventional SPECT systemsDay 0Evaluation will be made by an experienced observer (senior physician of the nuclear medicine department), for images obtained for each of the patients included, according to the Benamer's 5-category scale with 5 categories (normal, reduce type1, reduce type 2, reduce type 3, other reductions)

Secondary

MeasureTime frameDescription
Change in the Striatal Binding ratios (defined as ratio between striatal uptake and background uptake) between new and conventional SPECT systemsDay 0SBR obtained with each of the 2 methods, at the end of the optimal image acquisition time and at reduced time.
Evaluation of time reduction.Day 0Visual diagnostic classification of scintigraphic images on the Benamer scale when reducing the acquisition time, for each of the 2 acquisition methods.
Evaluation of time reductionDay 0visual diagnostic classification of scintigraphic images made by an experienced observer (senior physician of the nuclear medicine department), for the images obtained with each of the 2 scintigraphic methods used, for each of the patients included, on the simplified Benamer diagnostic scale with only 2 categories (category 1: normal images / other categories: abnormal images), at the end of the optimal time foreseen for the acquisition of the images as well as at reduced time.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026