Trial document





This trial has been registered retrospectively.
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  DRKS00011580

Trial Description

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Title

Quantification of the liver to lung shunt in Tc99m-MAA perfusion scintigraphy using SPECT/low-dose-CT: A Pilot Study

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Trial Acronym

Shunt-Quant

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URL of the Trial

[---]*

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Brief Summary in Lay Language

To prevent pulmonal damage caused by an excessive shunt of radioactive material used for selective intra-arterial radio-thromb-embolisation (SIRT) calculation of the liver to lung shunt (LLS) is necessary.
This study is set up to evaluate potential differences in LLS derived from planar Images on the one Hand and 3D-aided Evaluation on the other Hand.

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Brief Summary in Scientific Language

Today the prevalence of primary liver cancer and metastatic liver lesions is considerably high and rising. In an increasing number of cases selective internal radiotherapy (SIRT) is a powerful treatment option and recently published data demonstrates its potential in terms of prolonging survival in actual end stage patients.
Due to potential side-effects of SIRT a comprehensive and exact evaluation process has to be performed in advance. One of the side-effects to be aware of is a radiation induced pneumonitis cause by nuclide deposition in the lung based on liver-to-lung shunt (LLS). Ho et al. [Ho S. et al. Eur J Nucl Med 1997;24:293-298] defined strict limits for the LLS which, if exceeded, indicate either a dose reduction of Y90-SIRT (LLS>10%: dose reduction of 20%; LLS>15%: dose reduction of 40%) or even a cancellation of treatment (if LLS>20%), respectively.
In clinical routine LLS is calculated from planar images of Tc99m-MAA-perfusion scintigraphy as described by Murthy et al. [Murthy R. et al, Radiographics 2005 ;25:Suppl 1:41-55].
In the past decades hybrid imaging in means of Single Photon Emission Computed Tomography (SPECT) in combination with low-dose CT scans (SPECT/ldCT) arised as a potent modality for an exact estimation of nuclide deposition. Furthermore, due to the possibility of an anatomically correct and precise VOI-placement, significant differences between planar images and SPECT/ldCT in quantification processes have been described recently.
Therefore the aim of that study was to compare the results obtained from planar imaging to those derived from SPECT/ldCT and to record the potential influence of SPECT/ldCT on therapy.

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Organizational Data

  •   DRKS00011580
  •   2017/03/16
  •   [---]*
  •   yes
  •   Approved
  •   04/17, Ethikkommission der Medizinischen Fakultät der Otto-von-Guericke-Universität Magdeburg
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Secondary IDs

  •   RAD330  (interne Studien ID)
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Health Condition or Problem studied

  •   C78.7 -  Secondary malignant neoplasm of liver and intrahepatic bile duct
  •   C22 -  Malignant neoplasm of liver and intrahepatic bile ducts
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Interventions/Observational Groups

  •   retrospective analysis on SPECT/CT-data using semi-atomatic Software and comparison to planar scintigraphy
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

differences in LLS: planar scintigraphy vs. SPECT/ldCT

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Secondary Outcome

Potential influence of LLS-calculation, carried out by SPECT/ldCT, on clinical decision making

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/02/14
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   99   Years
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Additional Inclusion Criteria

Tc-99m-MAA-liver-perfusion-scintigraphy performed

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Exclusion Criteria

withdrawn consent

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinik für Radiologie und NuklearmedizinUniversität Magdeburg
    • Mr.  Prof.  Jens  Ricke 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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    • Klinik für Radiologie und Nuklearmedizin
    • Ms.  Christel  Besseler 
    • Leipziger Strasse 44
    • 39120  Magdeburg
    • Germany
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    • Klinik für Radiologie und Nuklearmedizin
    • Ms.  Christel  Besseler 
    • Leipziger Strasse 44
    • 39120  Magdeburg
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Radiologie und NuklearmedizinUniversität Magdeburg
    • Mr.  Prof.  Jens  Ricke 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2017/03/13
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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.