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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-A00070-45 | Other Identifier | RCB number |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients undergoing SPECT-CT | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Asir Image Acquisition | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Spect signal (kBq) | The Spect signal is measure on a 1 cm^3 zone of vertebrae L3. | 2 hours after inclusion (during SPECT-CT scan) |
| Spect noise (kBq) | The spect noise is carried out on a 1 cm^3 zone of the aorta | 2 hours after inclusion (during SPECT-CT scan) |
| Measure | Description | Time Frame |
|---|---|---|
| CT signal (HU) | measured on a 1 cm^3 zone of the aorta | 2 hours after inclusion (during SPECT-CT scan) |
| CT noise (HU) | measured on a 1 cm^3 zone of the aorta |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Louis Sibille, MD | Centre Hospitalier Universitaire de Nīmes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nîmes - Hôpital Universitaire Carémeau | Nîmes | Gard | 30029 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27013695 | Result | Sibille L, Chambert B, Alonso S, Barrau C, D'Estanque E, Al Tabaa Y, Collombier L, Demattei C, Kotzki PO, Boudousq V. Impact of the Adaptive Statistical Iterative Reconstruction Technique on Radiation Dose and Image Quality in Bone SPECT/CT. J Nucl Med. 2016 Jul;57(7):1091-5. doi: 10.2967/jnumed.115.164772. Epub 2016 Mar 24. |
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| 2 hours after inclusion (during SPECT-CT scan) |
| 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) |
| Radiation dose (mSv) | 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) |