SPECT-CTAsirTestNCT01800084
Impact of Reconstruction Method (ASIR, FBP) Used in CT on Bone SPECT/CT Image Quality
A study testing Asir Image Acquisition in people with SPECT-CT, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SPECT-CT
- What is being tested?
- Asir Image Acquisition
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2013to 28 May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the detailed description
The secondary objectives of this study are:
- 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.
- Check the concordance of two evaluations of image quality (Likert scale) made by nuclear medicine physicians (blinded to each other).
- Conditions
- SPECT-CT
- Being tested
- Asir Image Acquisition
- Keywords
- ASIR, image acquisition, FBP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Asir Image AcquisitionDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Asir Image Acquisition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spect signal (kBq)
The Spect signal is measure on a 1 cm^3 zone of vertebrae L3.
Measured: 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
Measured: 2 hours after inclusion (during SPECT-CT scan)
Secondary outcomes (8)
CT signal (HU)
measured on a 1 cm^3 zone of the aorta
Measured: 2 hours after inclusion (during SPECT-CT scan)
CT noise (HU)
measured on a 1 cm^3 zone of the aorta
Measured: 2 hours after inclusion (during SPECT-CT scan)
Ratio of CT signal / CT noise
Measured: 2 hours after inclusion (during SPECT-CT scan)
Spect image quality Likert scale ranging from 1 to 5, Evaluation n°1
Measured: 2 hours after inclusion (during SPECT-CT scan)
CT image quality Likert scale ranging from 1 to 5, Evaluation n°2
Measured: 2 hours after inclusion (during SPECT-CT scan)
Radiation dose (mSv)
Measured: 2 hours after inclusion (during SPECT-CT scan)
Spect image quality Likert scale ranging from 1 to 5, Evaluation n°2
Measured: 2 hours after inclusion (during SPECT-CT scan)
CT image quality Likert scale ranging from 1 to 5, Evaluation n°1
Measured: 2 hours after inclusion (during SPECT-CT scan)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2013 (estimated)
- Study startAug 2013
- Primary completion28 May 2014
- Study completion28 May 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SPECT-CTStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Louis Sibille, MD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01800084
- Sponsor's protocol ID
- LOCAL/2012/LS-01
- Other IDs
- 2013-A00070-45
- Acronym
- AsirTest
- Status last verified
- Mar 2015
- First submitted
- 25 Feb 2013
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27013695
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01800084
- Acronym / sponsor ID
- AsirTest / LOCAL/2012/LS-01
- Conditions
- SPECT-CT
- Keywords
- ASIR, image acquisition, FBP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- 28 May 2014 (actual)
- Study completion
- 28 May 2014 (actual)
- First posted
- 27 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- Check the concordance of two evaluations of image quality (Likert scale) made by nuclear medicine physicians (blinded to each other).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing SPECT-CT | Experimental | Device: Asir Image AcquisitionThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Asir 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. | Device | Patients undergoing SPECT-CT |
Primary outcome
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.
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
8 secondary outcomes
CT signal (HU)
Time frame: 2 hours after inclusion (during SPECT-CT scan)
CT noise (HU)
Time frame: 2 hours after inclusion (during SPECT-CT scan)
Ratio of CT signal / CT noise
Time frame: 2 hours after inclusion (during SPECT-CT scan)
Spect image quality Likert scale ranging from 1 to 5, Evaluation n°1
Time frame: 2 hours after inclusion (during SPECT-CT scan)
CT image quality Likert scale ranging from 1 to 5, Evaluation n°2
Time frame: 2 hours after inclusion (during SPECT-CT scan)
Radiation dose (mSv)
Time frame: 2 hours after inclusion (during SPECT-CT scan)
Spect image quality Likert scale ranging from 1 to 5, Evaluation n°2
Time frame: 2 hours after inclusion (during SPECT-CT scan)
CT image quality Likert scale ranging from 1 to 5, Evaluation n°1
Time frame: 2 hours after inclusion (during SPECT-CT scan)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Results publication: PubMed 27013695Sibille 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louis Sibille, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Asir Image Acquisition in people with SPECT-CT, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spect signal (kBq) (time frame: 2 hours after inclusion (during SPECT-CT scan)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01800084, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025; AzTrials last refreshed its copy on 6 Nov 2026.