Clinical trial NCT01800084: Impact of Reconstruction Method (ASIR, FBP) Used in CT on Bone SPECT/CT Image Quality
Official title: Impact of Reconstruction Method (Adaptive Statistical Iterative Reconstruction, Filtered Back Projection) Used in Computed Tomography on Bone Single-Photon- Emission-Computed-Tomography/Computed-Tomography Image Quality
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: SPECT-CT
Keywords: ASIR
image acquisition
FBP
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2013-02-27
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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).

Eligibility 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

Primary outcomes:
measure: Spect signal (kBq)
timeFrame: 2 hours after inclusion (during SPECT-CT scan)
measure: Spect noise (kBq)
timeFrame: 2 hours after inclusion (during SPECT-CT scan)
Secondary outcomes:
measure: CT signal (HU)
timeFrame: 2 hours after inclusion (during SPECT-CT scan)
measure: CT noise (HU)
timeFrame: 2 hours after inclusion (during SPECT-CT scan)
measure: Ratio of CT signal / CT noise
timeFrame: 2 hours after inclusion (during SPECT-CT scan)
measure: Spect image quality Likert scale ranging from 1 to 5, Evaluation n°1
timeFrame: 2 hours after inclusion (during SPECT-CT scan)
measure: CT image quality Likert scale ranging from 1 to 5, Evaluation n°2
timeFrame: 2 hours after inclusion (during SPECT-CT scan)
measure: Radiation dose (mSv)
timeFrame: 2 hours after inclusion (during SPECT-CT scan)
measure: Spect image quality Likert scale ranging from 1 to 5, Evaluation n°2
timeFrame: 2 hours after inclusion (during SPECT-CT scan)
measure: CT image quality Likert scale ranging from 1 to 5, Evaluation n°1
timeFrame: 2 hours after inclusion (during SPECT-CT scan)
Other outcomes:
Locations:
city: Nîmes Cedex 09
country: France
facility: CHU de Nîmes - Hôpital Universitaire Carémeau
state: Gard
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Louis Sibille, MD
role: PRINCIPAL_INVESTIGATOR
References: