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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Spect signal (kBq)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Spect signal (kBq)
时间窗: 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)
时间窗: 2 hours after inclusion (during SPECT-CT scan)
The spect noise is carried out on a 1 cm\^3 zone of the aorta
次要结局
- 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))
- CT noise (HU)(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))