Trial document




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  DRKS00006214

Trial Description

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Title

Application of a new image reconstruction algorithm (ASIR) for reducing radiation exposure in the Hybrid imaging by SPECT / low-dose CT: a prospective study

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Trial Acronym

ASIR/FBP

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The clinically indicated oncological SPECT / CT (single photon emission computed tomography/ computed tomography) of the upper abdomen operates with a CT tube current of 40mA. Those images are reconstructed with the FBP (filtered backprojection). The use of an iterative reconstruction algorithm (ASIR, adaptive statistical iterative reconstruction) and a CT tube current of 20mA could reduce (halves) the radiation exposure for the patient in imaging studies. Furthermore, image quality and especially image noise could be optimized.

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Brief Summary in Scientific Language

• Measurement of the effective radiation exposure and image quality after using 40mA (FBP) and 20mA (ASIR).
• objective and subjective comparison of image data sets by quantitative analysis (contrast, noise, uniformity) and assessment of image quality by reporting physicians in a "Blinded Read"

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Organizational Data

  •   DRKS00006214
  •   2014/07/14
  •   [---]*
  •   yes
  •   Approved
  •   78/14, Ethikkommission der Medizinischen Fakultät der Otto-von-Guericke-Universität Magdeburg
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Secondary IDs

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Health Condition or Problem studied

  •   Patients with oncology disease who get SPECT-CTs of abdomen
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Interventions/Observational Groups

  •   Image Optimization Study -
    All patients are evaluated with the same Image recording method -
    a) first each patient is examined by the standard method using computed tomography (40mA, FBP).
  •   b) Following all study patients are scanned with an additional low-dose CT (20mA, ASIR).

    This additional radiation exposure was specifically requested at the BfS.
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Basic research/physiological study
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

what: image quality at 20mA (ASIR) and 40mA (FBP).

how: Contrast-to-noise ratio (CNR).

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Secondary Outcome

what: effective radiation with 20mA (ASIR) and 40mA (FBP).
how: dosimetry.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/05/27
  •   59
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Patients with oncology disease who get SPECT-CTs of abdomen

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Exclusion Criteria

unable to comply with the inclusion criteria
younger than 18 years

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Magdeburg
    • Mr.  Prof.   Holger  Amthauer 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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    • Klinik für Radiologie und Nuklearmedizin
    • Mr.  Dr.  Oliver  Großer 
    • Leipziger Strasse 44
    • 39120  Magdeburg
    • Germany
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    • Klinik für Radiologie und Nuklearmedizin
    • Ms.  Anja  Zinke 
    • Leipziger Strasse 44
    • 39120  Magdeburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinik AöRMagdeburg
    • 39120  Magdeburg
    • Germany
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    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2016/11/01
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.