NCT01800084

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 27, 2013

Completed
5 months until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2014

Completed
Last Updated

November 17, 2025

Status Verified

March 1, 2015

Enrollment Period

10 months

First QC Date

February 25, 2013

Last Update Submit

November 14, 2025

Conditions

SPECT-CT

Keywords

ASIRimage acquisitionFBP

Outcome Measures

Primary Outcomes (2)

  • 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)

Secondary Outcomes (8)

  • 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)

  • +3 more secondary outcomes

Study Arms (1)

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

Device: Asir Image Acquisition

Interventions

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.

Patients undergoing SPECT-CT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • The patient is participating in another 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, Gard, 30029, France

Location

Related Publications (1)

  • 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.

    PMID: 27013695RESULT

Study Officials

  • Louis Sibille, MD

    Centre Hospitalier Universitaire de Nîmes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2013

First Posted

February 27, 2013

Study Start

August 1, 2013

Primary Completion

May 28, 2014

Study Completion

May 28, 2014

Last Updated

November 17, 2025

Record last verified: 2015-03

Locations

FR(1)