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Completed

NCT Number: NCT01800084

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

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.

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Key information

Conditions

SPECT-CT

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, Gard, 30029, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Spect signal (kBq)

    Time frame: 2 hours after inclusion (during SPECT-CT scan)

    The Spect signal is measure on a 1 cm^3 zone of vertebrae L3.

  2. Spect noise (kBq)

    Time frame: 2 hours after inclusion (during SPECT-CT scan)

    The spect noise is carried out on a 1 cm^3 zone of the aorta

Secondary outcomes

  1. CT signal (HU)

    Time frame: 2 hours after inclusion (during SPECT-CT scan)

    measured on a 1 cm^3 zone of the aorta

  2. CT noise (HU)

    Time frame: 2 hours after inclusion (during SPECT-CT scan)

    measured on a 1 cm^3 zone of the aorta

  3. Ratio of CT signal / CT noise

    Time frame: 2 hours after inclusion (during SPECT-CT scan)

  4. Spect image quality Likert scale ranging from 1 to 5, Evaluation n°1

    Time frame: 2 hours after inclusion (during SPECT-CT scan)

  5. CT image quality Likert scale ranging from 1 to 5, Evaluation n°2

    Time frame: 2 hours after inclusion (during SPECT-CT scan)

  6. Radiation dose (mSv)

    Time frame: 2 hours after inclusion (during SPECT-CT scan)

  7. Spect image quality Likert scale ranging from 1 to 5, Evaluation n°2

    Time frame: 2 hours after inclusion (during SPECT-CT scan)

  8. CT image quality Likert scale ranging from 1 to 5, Evaluation n°1

    Time frame: 2 hours after inclusion (during SPECT-CT scan)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study 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

Acronym: AsirTest

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 27, 2013
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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