Parkinson DiseaseSTARDATNCT04934046
Evaluation of Dopaminergic Denervation by DaTSCAN Brain Scintigraphy Using a New Multipurpose CZT System
A study testing Additional acquisition in people with Parkinson Disease, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Additional acquisition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- 2 Apr 2021to 2 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients referred to our Nuclear Medicine department for DaTSCAN scintigraphy.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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
- Being tested
- Additional acquisition
- Keywords
- DaTSCAN, Multipurpose CZT camera
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional acquisitionOther
Additional SPECT acquisition (30min added time approximately), with no added radiation
| Study group | Role | What they receive |
|---|---|---|
| DaTSCAN brain scan images from the new CZT SPECT system | Experimental | 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) Receives: Other: Additional acquisition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Day 0
Secondary outcomes (3)
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.
Measured: Day 0
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.
Measured: Day 0
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.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2021
- Study start2 Apr 2021
- Primary completion2 Dec 2022
- Study completion2 Dec 2022
Why it stopped: As the team at Nancy University Hospital published the same study last year, on the competing CZT 3D system (Veriton), our study is no longer relevant.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All patients will undergo SPECT acquisitions with both new multipurpose CZT camera and conventional SPECT camera.
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mattieu BAILLY, Dr, Principal investigator, CHR d'Orléans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04934046
- Sponsor's protocol ID
- CHRO-2020-21
- Acronym
- STARDAT
- Status last verified
- Jan 2024
- First submitted
- 9 Mar 2021
- Last updated
- 10 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 10830416Suwijn 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.
PubMed 25853018Kupsch 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.
PubMed 22492213Tolosa 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.
PubMed 17914722Djang 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.
PubMed 22159160
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04934046
- Acronym / sponsor ID
- STARDAT / CHRO-2020-21
- Conditions
- Parkinson Disease
- Keywords
- DaTSCAN, Multipurpose CZT camera
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: As the team at Nancy University Hospital published the same study last year, on the competing CZT 3D system (Veriton), our study is no longer relevant.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Study start
- 2 Apr 2021 (actual)
- Primary completion
- 2 Dec 2022 (actual)
- Study completion
- 2 Dec 2022 (actual)
- First posted
- 22 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patients will undergo SPECT acquisitions with both new multipurpose CZT camera and conventional SPECT camera.
| Arm | Type | Receives |
|---|---|---|
| DaTSCAN brain scan images from the new CZT SPECT system | Experimental | Other: Additional acquisitionAll 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients referred to our Nuclear Medicine department for DaTSCAN scintigraphy.
Key exclusion criteria (6 listed)
- Under 18 years-old patients.
- Pregnant women or at risk of pregnancy.
- Breast feeding.
- Painful patients.
- Patients under guardianship.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Additional acquisitionAdditional SPECT acquisition (30min added time approximately), with no added radiation | Other | DaTSCAN brain scan images from the new CZT SPECT system |
Primary outcome
Change in the visual Benamer Scale between new and conventional SPECT systems
Time frame: Day 0
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)
3 secondary outcomes
Change in the Striatal Binding ratios (defined as ratio between striatal uptake and background uptake) between new and conventional SPECT systems
Time frame: Day 0
Evaluation of time reduction.
Time frame: Day 0
Evaluation of time reduction
Time frame: Day 0
Results and safety
The study was stopped early (reason given: As the team at Nancy University Hospital published the same study last year, on the competing CZT 3D system (Veriton), our study is no longer relevant.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
- Background: PubMed 10830416Benamer 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.
- Background: PubMed 25853018Suwijn 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.
- Background: PubMed 22492213Kupsch 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.
- Background: PubMed 17914722Tolosa 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.
- Background: PubMed 22159160Djang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mattieu BAILLY, Dr principal investigator
CHR d'Orléans
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Additional acquisition in people with Parkinson Disease, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: As the team at Nancy University Hospital published the same study last year, on the competing CZT 3D system (Veriton), our study is no longer relevant.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the visual Benamer Scale between new and conventional SPECT systems (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04934046, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2024.