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

NCT ID: NCT04934046

Last Updated: 2024-01-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-02
• Study Completion Date: 2022-12-02

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

DaTSCAN brain scan images from the new CZT SPECT system

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)

Group Type: EXPERIMENTAL

Additional acquisition

Intervention Type: OTHER

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

Interventions

Additional acquisition

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

Intervention Type: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Régional d'Orléans

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mattieu BAILLY, Dr

Role: PRINCIPAL_INVESTIGATOR

CHR d'Orléans

Locations

CHR d'Orleans

Orléans, , France

Countries

France

References

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Reference Type: BACKGROUND

PMID: 10830416 (View on PubMed)

Suwijn SR, van Boheemen CJ, de Haan RJ, Tissingh G, Booij J, de Bie RM. The diagnostic accuracy of dopamine transporter SPECT imaging to detect nigrostriatal cell loss in patients with Parkinson's disease or clinically uncertain parkinsonism: a systematic review. EJNMMI Res. 2015 Mar 17;5:12. doi: 10.1186/s13550-015-0087-1. eCollection 2015.

Reference Type: BACKGROUND

PMID: 25853018 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 22492213 (View on PubMed)

Tolosa E, Borght TV, Moreno E; DaTSCAN Clinically Uncertain Parkinsonian Syndromes Study Group. Accuracy of DaTSCAN (123I-Ioflupane) SPECT in diagnosis of patients with clinically uncertain parkinsonism: 2-year follow-up of an open-label study. Mov Disord. 2007 Dec;22(16):2346-51. doi: 10.1002/mds.21710.

Reference Type: BACKGROUND

PMID: 17914722 (View on PubMed)

Djang DS, Janssen MJ, Bohnen N, Booij J, Henderson TA, Herholz K, Minoshima S, Rowe CC, Sabri O, Seibyl J, Van Berckel BN, Wanner M. SNM practice guideline for dopamine transporter imaging with 123I-ioflupane SPECT 1.0. J Nucl Med. 2012 Jan;53(1):154-63. doi: 10.2967/jnumed.111.100784. Epub 2011 Dec 8. No abstract available.

Reference Type: BACKGROUND

PMID: 22159160 (View on PubMed)

Other Identifiers

CHRO-2020-21

Identifier Type: -

Identifier Source: org_study_id