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

NCT04934046 | Terminated

• 1 other identifier: CHRO-2020-21
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

DaTSCAN; Multipurpose CZT camera

Outcome Measures

Primary Outcomes (1)

• 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)

  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

  Day 0

• Evaluation of time reduction.

  Day 0

• Evaluation of time reduction

  Day 0

Study Arms (1)

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)

Other: Additional acquisition

Interventions

Additional acquisition OTHER

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

DaTSCAN brain scan images from the new CZT SPECT system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients referred to our Nuclear Medicine department for DaTSCAN scintigraphy.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Centre Hospitalier Régional d'Orléans: lead

Study Sites (1)

CHR d'Orleans

Orléans, 45067, France

Location

Related Publications (5)

• 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.

  PMID: 10830416 BACKGROUND

• 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.

  PMID: 25853018 BACKGROUND

• 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.

  PMID: 22492213 BACKGROUND

• 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.

  PMID: 17914722 BACKGROUND

• 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.

  PMID: 22159160 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Mattieu BAILLY, Dr

  CHR d'Orléans

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: March 9, 2021
• First Posted: June 22, 2021
• Study Start: April 2, 2021
• Primary Completion: December 2, 2022
• Study Completion: December 2, 2022
• Last Updated: January 10, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)