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Latest Imaging SPECT System Evaluation Phase 1 (LISSE1)

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ClinicalTrials.gov Identifier: NCT04704349
Recruitment Status : Recruiting
First Posted : January 11, 2021
Last Update Posted : January 11, 2021
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Régional d'Orléans

Study Description
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Brief Summary:
Monocentric study for the evaluation of a whole body CZT scintigraphy system.

Condition or disease Intervention/treatment Phase
Rheumatic Disease Neoplasms Parathyroid Diseases Pulmonary Embolism Heart Diseases Thyroid Diseases Kidney Diseases Dementia Parkinsonian Disorders Radiation: Scintigraphy Not Applicable

Detailed Description:
Monocentric evaluation of performances and clinical interest of a whole body scintigraphic acquisition system with CZT digital detectors. Comparison of image quality and resolution of the new system compared to a reference one, on phantoms and during the acquisition of a wide variety of examinations.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 85 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: All patients will undergo scintigraphy on 2 distinct devices and the images obtained will be compared.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Latest Imaging SPECT System Evaluation Phase 1
Actual Study Start Date : October 5, 2020
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nuclear Scans

Arms and Interventions
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Arm Intervention/treatment
Experimental: Scintigraphy acquisitions
All patients will undergo scintigraphy on 2 distinct devices and the images obtained will be compared.
 Radiation: Scintigraphy
The scintigraphy of the patients will be carried out on 2 distinct devices and the images obtained will be compared.


Outcome Measures
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Primary Outcome Measures :
  1. Rate of images with a score greater than or equal to 4 [ Time Frame: Day 0 ]
    Rate of images obtaining a score greater than or equal to 4 in visual image quality analysis on a 5-point LIKERT scale.


Secondary Outcome Measures :
  1. collimator performance [ Time Frame: Day 0 ]
    Physical measurements of collimator performance on test object.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients referred to our Nuclear Medicine department for bone, cardiac, pulmonary, thyroid, parathyroid, renal or cerebral perfusion scintigraphy or to DaTSCAN.

Exclusion Criteria:

  • Under 18 years old patients.
  • Pregnant women or at risk of pregnancy.
  • Patients under guardianship
  • Painful patient (EVA>4)
  • Patients in whom a standard examination is not feasible (agitation).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04704349


Contacts
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Contact: Aurélie DESPUJOLS +33238744071 aurelie.despujols@chr-orleans.fr
Contact: Elodie POUGOUE TOUKO +33238744086 elodie.pougoue-touko@chr-orleans.fr

Locations
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France
CHR d'Orleans Recruiting
Orléans, France, 45067
Contact: Gilles METRARD, Dr       gilles.metrard@chr-orleans.fr   
Contact: Matthieu BAILLY, Dr       matthie.bailly@chr-orleans.fr   
Principal Investigator: Gilles METRARD, Dr         
Sponsors and Collaborators
Centre Hospitalier Régional d'Orléans
Investigators
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Principal Investigator: Gilles METRARD, Dr CHR Orléans
More Information
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Publications:

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Responsible Party: Centre Hospitalier Régional d'Orléans
ClinicalTrials.gov Identifier: NCT04704349    
Other Study ID Numbers: CHRO-2019-12
First Posted: January 11, 2021    Key Record Dates
Last Update Posted: January 11, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Régional d'Orléans:
Gamma camera
whole body scan
scintigraphy
Additional relevant MeSH terms:
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Rheumatic Diseases
Pulmonary Embolism
Parkinsonian Disorders
Kidney Diseases
Heart Diseases
Embolism
Collagen Diseases
Thyroid Diseases
Parathyroid Diseases
Urologic Diseases
Cardiovascular Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Embolism and Thrombosis
Vascular Diseases
Lung Diseases
Respiratory Tract Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Endocrine System Diseases
Basal Ganglia Diseases
Movement Disorders