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OpenTrials
Completed

NCT Number: NCT04704349

Latest Imaging SPECT System Evaluation Phase 1

Monocentric study for the evaluation of a whole body CZT scintigraphy system.

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Key information

Conditions

Rheumatic Disease Basal Ganglia Diseases Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Connective Tissue Diseases Dementia Embolism Embolism and Thrombosis Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Diseases Kidney Diseases Lung Diseases Male Urogenital Diseases Mental Disorders Movement Disorders Musculoskeletal Diseases Neoplasms Nervous System Diseases Neurocognitive Disorders Parathyroid Diseases Parkinsonian Disorders Pulmonary Embolism Respiratory Tract Diseases Rheumatic Diseases Skin and Connective Tissue Diseases Thyroid Diseases Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHR d'Orleans

Orléans, 45067, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Scintigraphy

Radiation

The scintigraphy of the patients will be carried out on 2 distinct devices and the images obtained will be compared.

Primary outcomes

  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 outcomes

  1. collimator performance

    Time frame: Day 0

    Physical measurements of collimator performance on test object.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional d'Orléans

Other

Registry information

Acronym: LISSE1

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 11, 2021
Registry last updated
Nov 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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