Impact of Reconstruction Method (ASIR, FBP) Used in CT on Bone SPECT/CT Image Quality (AsirTest)

Centre Hospitalier Universitaire de Nīmes

Status: Completed

Conditions: SPECT-CT

Treatments: Device: Asir Image Acquisition

Study type: Interventional

Funder types: Other

Identifiers

NCT01800084

LOCAL/2012/LS-01

2013-A00070-45 (Other Identifier)

Details and patient eligibility

About

The main objective of this study is to demonstrate the non-inferiority of SPECT image quality (as measured by the signal / noise ratio) obtained by ASIR reconstruction of very-low-dose CT acquisitions versus the quality of those obtained by filtered back projection (FBP) of low-dose CT acquisitions.

The lower limit of non-inferiority is set to -1, the average SPECT signal / noise ratio TEMP expected is between 5 and 6.

Full description

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).

Enrollment: 75 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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75 participants in 1 patient group

Patients undergoing SPECT-CT

Experimental group

Description:

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

Treatment:

Device: Asir Image Acquisition