LISSE1: Latest Imaging SPECT System Evaluation Phase 1

Sponsor

Centre Hospitalier Régional d'Orléans (Other)

Overall Status

Completed

CT.gov ID

NCT04704349

Collaborator

(none)

Enrollment

Location

Arm

3.7

Actual Duration (Months)

18.2

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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

Study Type:

Interventional

Actual Enrollment :

68 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.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 :

Oct 5, 2020

Actual Primary Completion Date :

Jan 27, 2021

Actual Study Completion Date :

Jan 27, 2021

Arms and Interventions

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.

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

Primary Outcome Measures

Rate of images with a score greater than or equal to 4 [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

collimator performance [Day 0]
Physical measurements of collimator performance on test object.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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