Completed

AsirTestReconstruction Methods in CT on Bone SPECT/CT Image Quality

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Study Aim

This study aims to evaluate how different reconstruction methods in computed tomography affect the image quality of bone scans in individuals undergoing SPECT/CT imaging.

What is being tested

Asir Image Acquisition

Device
Who is being recruted

Over 18 Years
See all eligibility criteria
How is the trial designed

Diagnostic Study

Interventional
Study Start: August 2013
See protocol details

Summary

Principal SponsorCentre Hospitalier Universitaire de Nīmes
Last updated: November 17, 2025
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2013

Actual date on which the first participant was enrolled.

The secondary objectives of this study are: A. Demonstrate the non-inferiority of image quality (as assessed by a Likert scale) obtained by ASIR-reconstruction-SPECT versus FBP-reconstruction (the lower-limit of non-inferiority is set at -0.5); B. Verify the non-inferiority of image quality (as measured by the signal / noise ratio)of CT images obtained by ASIR-reconstruction versus FBP-reconstruction (the lower-limit of non-inferiority is set at -0.2); C. Verify the non-inferiority of image quality (as assessed by the Likert scale) of CT images obtained by ASIR-reconstruction versus FBP-reconstruction (the lower limit of non-inferiority is set at -0.5); D. Check that the irradiation dose received by the patient is lower for the acquisition of images reconstructed with ASIR than for the acquisition of images reconstructed with FBP. E. Check the concordance of two evaluations of image quality (Likert scale) made by nuclear medicine physicians (blinded to each other).

NCT01800084
Principal SponsorCentre Hospitalier Universitaire de Nīmes
Last updated: November 17, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

75 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

Inclusion Criteria: The patient must have given his/her informed and signed consent The patient must be insured or beneficiary of a health insurance plan A SPECT-CT exam is scheduled for the patient The patient is able to withstand an extended position with the arms behind the head for 15 minutes (i.e. patient is able to undergo a SPECT-CT exam) Exclusion Criteria: The patient is participating in another study The patient is in an exclusion period determined by a previous study The patient is under judicial protection, or any kind of guardianship The patient refuses to sign the consent The patient has a contra-indication for a treatment necessary for this study (patient is not able to withstand an extended position with the arms behind the head for 15 minutes) It is impossible to correctly inform the patient The patient is pregnant, parturient, or breastfeeding Emergency situations Presence of osteosynthesis material (or any other material that would generate an artifact during SPECT-CT) in the spine Patient behaviour hampers image acquisition

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
The patients in this study are scheduled for a SPECT-CT at the Nîmes University Hospital as part of their normal care regimen. Intervention: Device: Asir Image Acquisition

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, FranceOpen CHU de Nîmes - Hôpital Universitaire Carémeau in Google Maps
CompletedOne Study Center