Trial document





This trial has been registered retrospectively.
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  DRKS00003936

Trial Description

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Title

Interindividual differences and influence of experience and level of training on FDG-PET based target volume delineation in radiation treatment planning of NSCLC.

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The integration of PET information into target volume delineation is reaching routine standard in many centers. Whilst the visual-manual delineation is the most common method used, mainly the automatic algorithms are in the focus of research. Only few approaches exist for the optimization of visual-manual delineation. Still unclear is the influence of experience and qualification. Therefore the aim of this study is to investigate this influence on inter-observer variability in target volume delineation in PET-based radiation treatment planning.

FDG-PET based Gross Tumor Volume (GTV) delineation was carried out on PET and CT images of one lung cancer patient. 45 persons (35 physicians, 10 medical students) delineated 36 GTVs and were divided into 4 groups according to their qualification and experience. Group E: Three international long-term research experts. Group EP: Nine two-person teams radiation oncologist (RO) & nuclear medicine physician (NMP). Group SFS: 13 other RO- or imaging clinicians. Group S: 10 medical students. The possible influence of years of experience with PET imaging was analyzed. Fife automatic delineation methods were included in the evaluation. Besides volume, values for concordance within the groups (pCI) and relative to the expert reference delineation (eCI) were calculated which are based on the Concordance Index.

The CT and PET data was collected retrospectively by anonymization of the image data of an appropriate patient from the treatment planning system of the Department of Radiation Medicine Freiburg, who explicitly agreed to the lead researcher to use the data for this reason.

For the patient whose anonymized CT and PET image data were used, no disadvantage was caused, since the PET and CT diagnosis was indeed already carried out in the course of treatment in 2008.

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Brief Summary in Scientific Language

To answer the question of the effect of experience and level of training on FDG PET based target volume delineation for treatment planning of non-small cell lung cancer, the participants of the study, who are physicians and medical students, delineated target volumes (GTV) on treatment planning systems on personal computers.
These target volume delineations were used for a comparison of the "inter-observer variability" between the participants, not for use on patients.
The CT and PET data was collected retrospectively by anonymization of the image data of an appropriate patient from the treatment planning system of the Department of Radiation Medicine Freiburg, who explicitly agreed to the lead researcher to use the data for this reason.
For the patient whose anonymized CT and PET image data were used, no disadvantage was caused, since the PET and CT diagnosis was indeed already carried out in the course of treatment in 2008.
The delineation of the target volumes of the participants took place from November 2009 to July 2011. Most participants participated at two courses where PET based target volume delineation skills were taught. Moreover, physicians and medical students of the University Hospital Freiburg participated in this delineation study. Additionally, three international experts were included. All participants agreed on the scientific use of their delineations for the purpose of this study

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Organizational Data

  •   DRKS00003936
  •   2012/11/15
  •   [---]*
  •   yes
  •   Approved
  •   249/11, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   lung cancer
  •   C34 -  Malignant neoplasm of bronchus and lung
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Interventions/Observational Groups

  •   Observational Group E: Three international experts in the field of PET-based radiation treatment planning with >10 years of clinical and scientific work. Delineation of one Gross Tumor Volume (GTV) per person.
  •   Observational Group EP: 9 two-person teams of a radiation oncologist and a nuclear medicine physician. Delineation of one Gross Tumor Volume (GTV) per team.
  •   Observational Group SFS: 13 single field specialists, mainly radiation oncologists. Delineation of one Gross Tumor Volume (GTV) per person.
  •   Observational Group S: 10 medical students. Delineation of one Gross Tumor Volume (GTV) per person.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Treatment
  •   Parallel
  •   N/A
  •   [---]*
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Primary Outcome

inter-observer variability

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Secondary Outcome

influence of experience and level of training

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2009/11/21
  •   36
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Medical students: completed the teaching course on radiotherapy and medical imaging.
Physicians: radiation oncologists and imaging specialists.

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Exclusion Criteria

Incomplete data of experience and level of training

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Addresses

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    • Universitätsklinikum Freiburg Klinik für Strahlenheilkunde
    • Ms.  Prof. Dr.  Ursula  Nestle 
    • Robert-Koch-Str. 3
    • 79106  Freiburg i.B.r
    • Germany
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    • Universitätsklinikum Freiburg Klinik für Strahlenheilkunde
    • Ms.  Prof. Dr.  Ursula  Nestle 
    • Robert-Koch-Str. 3
    • 79106  Freiburg i.B.r
    • Germany
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    • Universitätsklinikum Freiburg Klinik für Strahlenheilkunde
    • Ms.  Prof. Dr.  Ursula  Nestle 
    • Robert-Koch-Str. 3
    • 79106  Freiburg i.B.r
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Freiburg Klinik für Strahlenheilkunde
    • Ms.  Prof. Dr.  Ursula  Nestle 
    • Robert-Koch-Str. 3
    • 79106  Freiburg i.B.r
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2011/07/31
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* This entry means the parameter is not applicable or has not been set.