Evaluation of Dopaminergic Denervation by DaTSCAN Brain Scintigraphy Using a New Multipurpose CZT System (STARDAT)
Primary Purpose
Parkinson Disease
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Additional acquisition
Sponsored by
About this trial
This is an interventional other trial for Parkinson Disease focused on measuring DaTSCAN, Multipurpose CZT camera
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).
Sites / Locations
- CHR d'OrleansRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
DaTSCAN brain scan images from the new CZT SPECT system
Arm 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)
Outcomes
Primary Outcome Measures
Change in the visual Benamer Scale between new and conventional SPECT systems
Evaluation 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 Outcome Measures
Change in the Striatal Binding ratios (defined as ratio between striatal uptake and background uptake) between new and conventional SPECT systems
SBR obtained with each of the 2 methods, at the end of the optimal image acquisition time and at reduced time.
Evaluation of time reduction.
Visual diagnostic classification of scintigraphic images on the Benamer scale when reducing the acquisition time, for each of the 2 acquisition methods.
Evaluation of time reduction
visual 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.
Full Information
NCT ID
NCT04934046
First Posted
March 9, 2021
Last Updated
December 27, 2022
Sponsor
Centre Hospitalier Régional d'Orléans
1. Study Identification
Unique Protocol Identification Number
NCT04934046
Brief Title
Evaluation of Dopaminergic Denervation by DaTSCAN Brain Scintigraphy Using a New Multipurpose CZT System
Acronym
STARDAT
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
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 2, 2021 (Actual)
Primary Completion Date
April 2, 2024 (Anticipated)
Study Completion Date
April 2, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Régional d'Orléans
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
DaTSCAN, Multipurpose CZT camera
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All patients will undergo SPECT acquisitions with both new multipurpose CZT camera and conventional SPECT camera.
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
DaTSCAN brain scan images from the new CZT SPECT system
Arm Type
Experimental
Arm 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)
Intervention Type
Other
Intervention Name(s)
Additional acquisition
Intervention Description
Additional SPECT acquisition (30min added time approximately), with no added radiation
Primary Outcome Measure Information:
Title
Change in the visual Benamer Scale between new and conventional SPECT systems
Description
Evaluation 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)
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Change in the Striatal Binding ratios (defined as ratio between striatal uptake and background uptake) between new and conventional SPECT systems
Description
SBR obtained with each of the 2 methods, at the end of the optimal image acquisition time and at reduced time.
Time Frame
Day 0
Title
Evaluation of time reduction.
Description
Visual diagnostic classification of scintigraphic images on the Benamer scale when reducing the acquisition time, for each of the 2 acquisition methods.
Time Frame
Day 0
Title
Evaluation of time reduction
Description
visual 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.
Time Frame
Day 0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthieu BAILLY, Dr
Phone
+33238575078
Email
matthieu.bailly@chr-orleans.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mattieu BAILLY, Dr
Organizational Affiliation
CHR d'Orléans
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHR d'Orleans
City
Orléans
ZIP/Postal Code
45067
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthieu BAILLY, Dr
Email
matthie.bailly@chr-orleans.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
10830416
Citation
Benamer TS, Patterson J, Grosset DG, Booij J, de Bruin K, van Royen E, Speelman JD, Horstink MH, Sips HJ, Dierckx RA, Versijpt J, Decoo D, Van Der Linden C, Hadley DM, Doder M, Lees AJ, Costa DC, Gacinovic S, Oertel WH, Pogarell O, Hoeffken H, Joseph K, Tatsch K, Schwarz J, Ries V. Accurate differentiation of parkinsonism and essential tremor using visual assessment of [123I]-FP-CIT SPECT imaging: the [123I]-FP-CIT study group. Mov Disord. 2000 May;15(3):503-10.
Results Reference
background
PubMed Identifier
25853018
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.
Results Reference
background
PubMed Identifier
22492213
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.
Results Reference
background
PubMed Identifier
17914722
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.
Results Reference
background
PubMed Identifier
22159160
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.
Results Reference
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Evaluation of Dopaminergic Denervation by DaTSCAN Brain Scintigraphy Using a New Multipurpose CZT System
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