Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00014346

Trial Description

start of 1:1-Block title

Title

Prospective evaluation of the comparability of different imaging methods for the detection and characterization of sentinel lymph nodes in cervical cancer and endometrial carcinoma

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

Trial Acronym

SLN-Gyn_TÜ-016

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

Both, for endometrial carcinoma and cervical carcinoma the primary therapy option is the removal of the tumor by surgery. In addition the nearest neighboring lymph nodes, the so called sentinel lymph nodes, will be removed as well and analyzed very carefully. For further therapy planning it is very important to know whether they are affected by the tumor or not. At the university hospital in Tübingen the combined positron emissions-/magnetic resonance-tomography (PET/MRT) is used in most cases for the op-planning.
During this observational trial we like to analyse the suitability of different imaging methods for the detection of tumor-infiltrated sentinel lymph nodes.

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

Brief Summary in Scientific Language

Both, endometrial carcinoma and cervical carcinoma belong to the most frequent oncologic diseases of women. For both cancer types the early detection - and in case of advanced disease the surgical complete removal of lymph node metastases - are important prognostic factors. Lymphadenectomy is the gold standard but technical challenging and frequently associated with high morbidity. For the surgeon as well as for the patient a preferably exact op-planning by pre-op imaging is of importance and helps to minimize the extent of the surgery. Today, different methods are in use for the detection of sentinel lymphnodes (SLN). Goal of this prospective observational trial is to correlate the performed PET/MRI for clinical staging with the histopathological analysis of SLN (gold standard) and other SLN-diagnostic procedures (Tc 99m-MAA SPECT/CT, intra-op staining methods). It is expected that a distinct localization of the SLN together with information on its tumor cell positivity prior to surgery will help to minimize the morbidity of lymphadenectomy. Moreover, this setting will allow correlating PET/MR datasets with quantitative SPECT/CT and (semi)quantitative immunopathological methods. This will help to analyze the lower detection limit of tumor cells in defined SLN-volumes, either by PET (SUV) or MRI (DWI).

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

Organizational Data

  •   DRKS00014346
  •   2018/04/09
  •   [---]*
  •   yes
  •   Approved
  •   173/2015BO1, 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

  •   C54.1 -  Malignant neoplasm: Endometrium
  •   C53 -  Malignant neoplasm of cervix uteri
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Observational group: patients with endometrial or cervical cancer having different methods for the analysis of SLN (sentinel lymph nodes).
    Goal of this prospective observational trial is to correlate the performed PET/MRI for clinical staging with the histopathological analysis of SLN (gold standard) and other SLN-diagnostic procedures (Tc 99m-MAA SPECT/CT, intra-op staining methods). It is expected that a distinct localization of the SLN together with information on its tumor cell positivity prior to surgery will help to minimize the morbidity of lymphadenectomy.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   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

Correlation of different imaging methods for the detection of SLN (SPECT/CT, intra-op staining methods, PET/MRT) – among each other and in correlation to gold standard (immunohistological analysis) – for the pre-op localization of tumor-positive / tumor-negative SLN

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

Secondary Outcome

What is the predictive value of the combination of different imaging methods for tumor-positive SLN?
To do so: evaluation of sensitivity, specificity, accuracy as well as positive/negative predictive value of single imaging methods or combinations thereof for the detection of positive/negative SLN in patients with endometrial or cervical cancer – compared to gold standard (histopathological analyses of SLN).

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

  •   Actual
  •   2016/03/08
  •   333
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Female
  •   18   Years
  •   99   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

- Patients with cervical cancer or endometrial cancer with a clinical indication for PET/MRT-examination for i) primary staging or re-staging in advanced disease, ii) unclear diagnosis based on conventional imaging procedures for op-planning, iii) pre-op exclusion of pelvine metastasis in case of pelvine relapse
- Age: ≥18 years
- Written informent consent

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

Exclusion Criteria

- Histologic type of carcinosarcoma or other rare entities
- Precnancy or breast feeding women
- No written informed consent

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Tübingen
    • Geissweg 3
    • 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 other
    • Universitätsklinikum TübingenRadiologische Klinik
    • Mr.  Prof. Dr.  Konstantin  Nikolaou 
    • Hoppe-Seyler-Str. 3
    • 72076  Tübingen
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • Universitätsklinikum Tübingen, Institut für Pathologie und Neuropathologie, Abteilung Allgemeine und Molekulare Pathologie und Pathologische Anatomie
    • Mr.  Prof. Dr.  Falko  Fend 
    • Liebermeisterstraße 8
    • 72076  Tübingen
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Universitätsklinikum Tübingen, Radiologische Klinik, Nuklearmedizin und Klinische Molekulare Bildgebung
    • Mr.  Prof. Dr.  Christian  la Fougere 
    • 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, Frauenklinik
    • Ms.  Prof. Dr.  Sara  Brucker 
    • Calwerstrasse 7
    • 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
    • Universitätsklinikum Tübingen
    • Geissweg 3
    • 72076  Tübingen
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
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.