Trial document




drksid header

  DRKS00017717

Trial Description

start of 1:1-Block title

Title

Dynamic whole-body [18F]FDG-PET/CT for patients with lung cancer

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

dynPET_NSCLC

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Lung cancer is the most common cause of cancer death in Germany.
For the determination of the best therapy an exact propagation diagnostics is necessary, which can differentiate between inflammatory events and tumor tissue in the lung. The combined PET/CT, which determines the energy turnover of cells with a sugar-based radiotracer, is suitable for this purpose. However, an exact distinction of e.g. inflammatory lymph nodes and lymph node metastases is also difficult with this technique, since both types of tissue metabolize sugar intensified.
The use of the so-called dynamic PET, which is being tested in this study, should be accompanied by a higher specificity for the distinction between inflammatory and tumorous energy metabolism, since the sugar offered by the tracer is converted at different rates by different cell types.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Lung cancer is the most common cancer death cause in Germany.
Therapy planning and prognosis require an exact diagnosis of the spread, in particular of lymph node and distant metastases. FDG-PET/CT is currently the method of choice. However, exact differentiation between inflammatory lymph nodes and mediastinal lymph node metastases remains a major challenge as both have increased glucose metabolism.
The use of dynamic PET should be associated with a higher specificity for the differentiation between inflammatory and tumorous glucose metabolism, as there are significant differences in FDG-kinetics between inflammatory processes and the tumor tissue.
In this diagnostic study, dynamic FDG parameters of the whole body are to be recorded, analyzed and correlated with histopathological data as well as the therapy outcome by means of a multi-bed-multi-timepoint technique using a larger, representative patient collective. In addition to standard clinical findings, dynamic PET parameters (Ki, DV, K1, and Vb), SUV parameters, and CT morphological findings are collected and correlated with histopathology as the gold standard.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00017717
  •   2019/08/01
  •   [---]*
  •   yes
  •   Approved
  •   333/2019BO1, Ethik-Kommission an der Medizinischen Fakultät der Eberhard-Karls-Universität und am Universitätsklinikum Tübingen
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   C34 -  Malignant neoplasm of bronchus and lung
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Patients with suspected or histologically confirmed NSCLC who are clinically indicated for FDG PET/CT.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Collection of dynamic PET parameters (Ki, DV, K1 and Vb) from the primary tumor, lymph node regions and distant metastases of NSCLC patients and their correlation with histopathological findings ("gold standard") of the same regions (feasibility study). Histopathological analyzes are performed on biopsies or surgical material collected as part of the routine care of patients.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

• Differentiation of inflammatory and tumor-associated tissue changes by means of suitable dynamic PET parameters,
• Identification of malignant lymph nodes using dynamic PET parameters,
• Establishment of the workflow for a dynamic wb-PET/CT in NSCLC patients.
(Endpoint of the study: PET/CT datasets and immunhistol. analyses of tissue probes (taken as part of standard of care) are available)

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Planned
  •   2019/08/15
  •   38
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   100   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

• Patients with clinical suspicion or histologically confirmed NSCLC ((non small cell lung carcinoma)
• Justifying clinical indication for a [18F]FDG-PET investigation
• Patients who tolerate 1 h measurement time in the PET/CT scanner
• Age ≥18 years
• Written consent of the patient

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

• pregnant and nursing women
• Patients with claustrophobia
• Patients with back pain problems / pain that may not tolerate a one-hour measurement period
• Exclusion criteria according to German StrlSchV
• Limited ability to consent of the patient

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Tübingen, Nuklearmedizin
    • Mr.  Prof. Dr.  Christian  la Fougere 
    • 72076  Tübingen
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Universitätsklinikum Tübingen, Nuklearmedizin
    • Mr.  Dr.  Matthias   Weissinger 
    • Otfried-Müller-Straße 14
    • 72076  Tübingen
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Universitätsklinikum Tübingen, Nuklearmedizin
    • Mr.  Dr.  Matthias  Weissinger 
    • Otfried-Müller-Straße 14
    • 72076  Tübingen
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Siemens Healthineers
    • 91052  Erlangen
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
  • start of 1:1-Block address otherSupport
    • Universitätsklinikum Tübingen
    • Geissweg 3
    • 72076  Tübingen
    • Germany
    end of 1:1-Block address otherSupport
    start of 1:1-Block address contact otherSupport
    end of 1:1-Block address contact otherSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting planned
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.