Clinical trial NCT04934046: Evaluation of Dopaminergic Denervation by DaTSCAN Brain Scintigraphy Using a New Multipurpose CZT System
Official title: Clinical Evaluation of a New Multipurpose Whole-body CZT Camera in DaTSCAN Brain Scintigraphy: a Head-to-head Comparison With a Conventional System.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Parkinson Disease
Keywords: DaTSCAN
Multipurpose CZT camera
Lead sponsor: Centre Hospitalier Régional d'Orléans
Sponsor class: OTHER
First posted: 2021-06-22
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All patients will undergo SPECT acquisitions with both new multipurpose CZT camera and conventional SPECT camera.
Primary purpose: OTHER

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.

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).

Primary outcomes:
measure: Change in the visual Benamer Scale between new and conventional SPECT systems
timeFrame: Day 0
Secondary outcomes:
measure: Change in the Striatal Binding ratios (defined as ratio between striatal uptake and background uptake) between new and conventional SPECT systems
timeFrame: Day 0
measure: Evaluation of time reduction.
timeFrame: Day 0
measure: Evaluation of time reduction
timeFrame: Day 0
Other outcomes:
Locations:
city: Orléans
country: France
facility: CHR d'Orleans
Study officials:
affiliation: CHR d'Orléans
name: Mattieu BAILLY, Dr
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: Kupsch AR, Bajaj N, Weiland F, Tartaglione A, Klutmann S, Buitendyk M, Sherwin P, Tate A, Grachev ID. Impact of DaTscan SPECT imaging on clinical management, diagnosis, confidence of diagnosis, quality of life, health resource use and safety in patients with clinically uncertain parkinsonian syndromes: a prospective 1-year follow-up of an open-label controlled study. J Neurol Neurosurg Psychiatry. 2012 Jun;83(6):620-8. doi: 10.1136/jnnp-2011-301695. Epub 2012 Apr 6.
citation: 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.
citation: 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.