Trial document





This trial has been registered retrospectively.
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  DRKS00011494

Trial Description

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Title

RAD328 Quantification of lobe-based lung function: comparison of planar scintigraphy, SPECT and SPECT/CT – a pilot study

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Trial Acronym

Q-plaS-pilot

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URL of the Trial

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Brief Summary in Lay Language

Before lung operation there is the necessity for clarification of lobe-based assessment of percental function in some cases.
This is routinely done by lung-perfusion-scintigraphy. Recent data comparing planar scintigraphy (2D, present clinical Standard) and 3D-based calculation (in means of SPECT/low-dose-CT; 3D-imaging of perfusion + low-dose CT) is promising.
Nevertheless the 3D-Approach, if carried out manually, is difficult and ressource-consuming which hampers a standard implementation into clinical routine.
New software allows semi-automatic processing of the 3D-data.
Aim of this retrospective study is (a) to find out if there are significant differences between the planar and the 3D-based Approach (for both 3D-approaches) and (b) if there are significant differences between a fully manual evaluation of SPECT/low-dose-CT and a semi-automatic approach.

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Brief Summary in Scientific Language

In case of pulmonal malignoma patients are usually scheduled for surgery. Before therapy there is a need for preoperative estimation of lung function for clarification of functional resectability. This is usually done by calculating the percentage of lung function for each lobe from lung perfusion scan. In combination with the forced pre-operative lung capacity (FEV1) the post operative functional capacity has to be predicted. A cut-off value of FEV1> 2.0 l is sufficient for pneumectomie without further pre operative examinations.

Due to the implementation of hybrid imaging in means of SPECT/low-dose-CT (SPECT/LD-CT) diagnostics can be improved. The lobar perfusion can be quantified by using volumes-of-interest (VOI) from simultaneous acquired CT imaging. Besides, SPECT images were corrected for attenuation and scattering.

The aim of our retrospective study is to compare the lobar lung function estimated by scintigraphy and SPECT/low-dose-CT.

In addition to that we want to compare a manual and a semi-automatic approach for quantification from SPECT/low-dose-CT.

Furthermore we want to evaluate the interrater agreement using the semi-automatic approach.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00011494
  •   2017/03/02
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  •   no
  •   Approved
  •   184/16, Ethikkommission der Medizinischen Fakultät der Otto-von-Guericke-Universität Magdeburg
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Secondary IDs

  •   RAD328  (interne Studiennummer)
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Health Condition or Problem studied

  •   C34 -  Malignant neoplasm of bronchus and lung
  •   C78.0 -  Secondary malignant neoplasm of lung
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Interventions/Observational Groups

  •   Retrospective inclusion of patients who underwent lung scintigraphy in SPECT/low-dose-CT for clinical reasons.

    Calculation of lobe-based pulmonary function:
    1. planar scintigraphy; 2D; clinical Standard
    2. manually from SPECT/low-dose-CT
    3. semi-automatic using specific Software (3 Reader; blinded to each other and to clinical Information)
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Basic research/physiological study
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

data from planar scintigraphy and SPECT/low-dose-CT (both, the manual and the semi-automatic approach) differ significantly

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Secondary Outcome

1. There is no difference between manual and semi-automatic evaluation of SPECT/low-dose-CT.
2. Results from semi-automatic quantification are investigator independent

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/01/18
  •   39
  •   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

exploitable SPECT/low-dose-CT of the lung

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Exclusion Criteria

withdrawn informed consent

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Addresses

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    • Universitätsklinikum Magdeburg
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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    • Universitätsklinikum Magdeburg A.ö.R.
    • Mr.  Dr. rer. nat.  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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    • 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
  •   2018/06/01
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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.