Clinical Trials Directory

Trials / Completed

CompletedNCT01800084

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
75 (actual)
Sponsor
Centre Hospitalier Universitaire de Nīmes · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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).

Conditions

Interventions

TypeNameDescription
DEVICEAsir Image AcquisitionIn 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.

Timeline

Start date
2013-08-01
Primary completion
2014-05-28
Completion
2014-05-28
First posted
2013-02-27
Last updated
2025-11-17

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT01800084. Inclusion in this directory is not an endorsement.