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

Not Applicable

Completed

• Conditions: SPECT-CT
• Interventions: Device: Asir Image Acquisition

• Registration Number: NCT01800084
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

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.

Detailed 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).

Study Timeline

• Study First Submitted: 2013-02-25
• Study First Submitted QC: 2013-02-25
• Study First Posted: 2013-02-27
• Study Start: 2013-08
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-25
• Last Update Posted: 2015-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients undergoing SPECT-CT	Asir Image Acquisition	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

Primary Outcome Measures

Name	Time	Method
Spect signal (kBq)	2 hours after inclusion (during SPECT-CT scan)	The Spect signal is measure on a 1 cm\^3 zone of vertebrae L3.
Spect noise (kBq)	2 hours after inclusion (during SPECT-CT scan)	The spect noise is carried out on a 1 cm\^3 zone of the aorta

Secondary Outcome Measures

Name	Time	Method
CT noise (HU)	2 hours after inclusion (during SPECT-CT scan)	measured on a 1 cm\^3 zone of the aorta
Ratio of CT signal / CT noise	2 hours after inclusion (during SPECT-CT scan)
Spect image quality Likert scale ranging from 1 to 5, Evaluation n°1	2 hours after inclusion (during SPECT-CT scan)
CT image quality Likert scale ranging from 1 to 5, Evaluation n°2	2 hours after inclusion (during SPECT-CT scan)
Spect image quality Likert scale ranging from 1 to 5, Evaluation n°2	2 hours after inclusion (during SPECT-CT scan)
CT image quality Likert scale ranging from 1 to 5, Evaluation n°1	2 hours after inclusion (during SPECT-CT scan)
CT signal (HU)	2 hours after inclusion (during SPECT-CT scan)	measured on a 1 cm\^3 zone of the aorta
Radiation dose (mSv)	2 hours after inclusion (during SPECT-CT scan)

Trial Locations

Locations (1)

CHU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 09, Gard, France