SPECT-CT
Conditions
Keywords
ASIR, image acquisition, FBP
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).
Interventions
DEVICEAsir Image Acquisition
In addition to their normal image acquisition, a supplementary image acquisition lasting approximately 20 seconds (i.e. an ASIR image acquisition) will be carried out for each patient.
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | — |
| CT signal (HU) | 2 hours after inclusion (during SPECT-CT scan) | measured on a 1 cm\^3 zone of the aorta |
| 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) | — |
| Radiation dose (mSv) | 2 hours after inclusion (during SPECT-CT scan) | — |
| CT noise (HU) | 2 hours after inclusion (during SPECT-CT scan) | measured on a 1 cm\^3 zone of the aorta |
Countries
France
Outcome results
None listed