Trial document



drksid header

  DRKS00013169

Trial Description

start of 1:1-Block title

Title

Tattooing suspicious axillary lymph nodes in breast cancer patients treated by primary systemic therapy

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

Trial Acronym

Tattoo

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

The aim of the study is to investigate the feasibility of tattoing and identifying metastatic axillary lymph nodes in breast cancer patients receiving primary chemotherapy. Up to 74% of these patients of these patients convert to node negative after chemotherapy and in these cases complete axillary dissection is an overtreatment. Sentinel lymph node biopsy in these patients is not accuratly enough and has low detection rates. A previous study in 12 patients has shown a detection of tattowed lymph nodes after primary chemotherapy during surgery in all cases (Choy et al. 2015). This result has to be proved in a larger number of patients. All breast cancer patients treated at the university of Rostock receiving primary chemotherapy without distant metastases can be paticipants of this trial. In these patients higly purifid carbon solution is injected into the suspicious axillary lymphnode, which we hope to find easily during surgery.

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

Brief Summary in Scientific Language

The aim of the study is to investigate the feasibility of tattoing and identifying metastatic axillary lymph nodes in breast cancer patients receiving primary systemic therapy. Up to 74% of these patients of these patients convert to node negative after chemotherapy and in these cases complete axillary dissection is an overtreatment. SLNB in these patients has unacceptable false-negative rates and clip-marked lymph nodes have low detection rates. A previous study in 12 patients has shown a detection of tattowed lymph nodes after primary systemic therapy during surgery in all cases (Choy et al. 2015).
Amendment 1 18.04.2018: number of patients n=100, multicentric study

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

Organizational Data

  •   DRKS00013169
  •   2017/10/24
  •   [---]*
  •   yes
  •   Approved
  •   A 2017-0142, Ethik-Kommission an der Medizinischen Fakultät der Universität Rostock
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

  •   breast cancer
  •   C50 -  Malignant neoplasm of breast
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   14G-Core needle biopsy and tattoing (highly purified carbon solution: 0,1-0,5ml Spot) of the largest suspicious axillary under ultrasound guidance and documentation prior primary systemic therapy
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

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

Primary Outcome

detection rate of charcoal tattoed metastatic axillary lymph nodes during surgery after primary systemic therapy in breast cancer patients

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

Secondary Outcome

- concordance of SLN and tattooed LN
- predictive value of tattoed LN for residual metastatic disease in other axillary lymph nodes
- complications caused by tattoing axillary lymph nodes (regarding injection until surgery)

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

Countries of Recruitment

  •   Germany
  •   Sweden
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
  •   2017/11/07
  •   100
  •   Multicenter trial
  •   International
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

All patients with primay breast cancer (c/iT1-T4c, uni- or bilateral) diagnosed at the university of Rostock, treated by primary systemic therapy presenting with suspicious axillary lymph nodes (c/i N+) without distant metastases.

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

Exclusion Criteria

- male patients
- pregnancy
- age < 18 Years
- distant metastases
- no informed consent

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsfrauenklinik Rostock
    • Südring 81
    • 18059  Rostock
    • 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
    • Universitätsfrauenklinik Rostock
    • Ms.  Dr. med.  Steffi  Hartmann 
    • Südring 81
    • 18059  Rostock
    • 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
    • Universitätsfrauenklinik
    • Ms.  Dr. med.  Steffi  Hartmann 
    • Südring 81
    • 18059  Rostock
    • 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
    • Universitätsfrauenklinik Rostock
    • Südring 81
    • 18059  Rostock
    • 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 complete, follow-up continuing
  •   [---]*
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.