Trial document




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  DRKS00007719

Trial Description

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Title

3D-based Sentinel Lymph Node Diagnosis and Biopsy in Head and Neck Cancer

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Trial Acronym

SLNOSCC

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

1.1 Background
Sentinel lymph node biopsy (SLNB) is a well known technique in some tumours (e.g. melanoma, breast cancer). Sentinel lymph nodes are the first draining lymph nodes from the cancer sites. Checking these lymph nodes for metastases proves progression of the cancer (Vogt 2010). For Head and Neck Cacner lymph node metastases are one of the most important relevant parameters (Sloan 2009, Stoeckli 2009). With positive lymph nodes 5 year overall survival drops from 82% to 53% (Stoeckli 2009). In Germany the neck dissection is part of the surgical treatment of Head and Neck Cancer according to tumour stage and localisation. Even if the preoperative staging shows no positive lymph nodes (cN0) an elective neck dissection is performed due to 25-30% patients with occult metastases (Ferito 2009). This also means that about 70% of all patients receive an overtreatment with this neck dissection. SLNB has sensitivity of about 95% and negative predicitvie value of also 95% that makes it a possible alternative procedure for neck dissection. Advantages are reduced morbidity, less complications and identification of atypical lymphatic drainage (Sloan 2009, Stoeckli 2012). Civantos identified 13,6% sentinel lymph in atypical lymphatic drainage pattern (Civantos 2006). SLN is a safe procedure and show relapse rates comparable to neck dissection of 6-7% (Stoeckli 2006, 2012).
In 2005 „The Second International Conference on Sentinel Node Biopsy in Mucosal Head and Neck Cancer“ recommended SLNB for cT1/2 cN0 Head and Neck Cancer (Stoeckli 2005, 2007). In 2009 a technical advise of The European Association of Nuclear Medicine (EANM) and The Sentinel Node Biopsy Trail (SENT) for these tumours was published (Alkureishi 2009). Other publications recommend a neck dissection only in positive necks (cN+) (Chepeha 2002, Kuntz 1999, Rogers 2004). In T3/4 tumours SLNB is controversially discussed (Antonio 2012, Ross 2002).
In several studies limited detection rates of SLN in proximity to the tumour bed were reported (esp. in floor of the mouth tumours). Detection rates dropped from 96% to 86% (Alkureishi 2009, Coughlin 2010). This is one reason to advocate neck dissection in Germany.
In this study in the Dpt. of Oral and Maxillofacial Plastic Surgery the SLNB according to the guidelines resp. recommendations of The German Society of Nuclear Medicine (DGNM), The European Association of Nuclear Medicine (EANM) will established and in addition to the conventional gamma-probe a intraoperative freehand-SPECT will be acquired (Vogt H 2010, Alkureishi 2009).


1.2 Aim of the study
„The second International Conference on Sentinel Node Biopsy in Mucosal Head and Neck Cancer“ (Stoeckli 2005) recommended the use of SLNB only in validation studies taking a learning curve of the surgeon into account that causes often biases. After SLNB an elective neck dissection should be performed. This procedure secures patient safety and facilitates a control of the method. SLN and the other lymph nodes will be checked separately for metastases by a pathologist.
Aim is to determine sensitivity, specifity, detection rate, negative predicitive value and compare theit measures with the values stated in the guidelines. This might lead to a reduced number of elective neck dissection and reduced morbidity for the patients. The study will include T1/2 tumours and compare them to T3/4 tumours, both with cN0 state.

Secundary aim
In addition to the conventional gamma probe a freehand-SPECT will be used intraoperatively for measuring and depicting the distribution of the radionucleotide in the operation field. This might show especially advantages for this technique in detection of SLN especially in proximity to the tumour bed.

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Organizational Data

  •   DRKS00007719
  •   2015/01/26
  •   [---]*
  •   yes
  •   Approved
  •   305/12, Ethik-Kommission der Medizinischen Fakultät der Universität Würzburg
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Secondary IDs

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

  •   C00 -  Malignant neoplasm of lip
  •   C01 -  Malignant neoplasm of base of tongue
  •   C02 -  Malignant neoplasm of other and unspecified parts of tongue
  •   C03 -  Malignant neoplasm of gum
  •   C04 -  Malignant neoplasm of floor of mouth
  •   C05 -  Malignant neoplasm of palate
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Interventions/Observational Groups

  •   Oral and Oropharyngeal Carcinoma stadium T1/2 andcN0.
    Preoperative a lymphscintigraphy is performed and intraoperative a sentinel lymph node biopsy via the SurgicEye(R)-tool is performed.
  •   Oral and Oropharyngeal Carcinoma stadium T3/4 andcN0.
    Preoperative a lymphscintigraphy is performed and intraoperative a sentinel lymph node biopsy via the SurgicEye(R)-tool is performed.
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Aim of the study is to evaluate detection rate, sensitivity, specifity and negative predictive value for SLN in comparison with the values from the guidelines. This will be checked using a lymphscintigraphy and the SurgicEye(R)-tool.

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Secondary Outcome

In addition to the conventional gamma probe a freehand-SPECT will be used intraoperatively for measuring and depicting the distribution of the radionucleotide in the operation field. This might show especially advantages for this technique in detection of SLN especially in proximity to the tumour bed. Also the frequency the surgeon uses the 3D-presentation will be recorded.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Planned
  •   2015/06/01
  •   30
  •   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

EANM Practice Guideline:
Patients with oral and oro-pharyngeal carcinoma with the stages cT1/T2 and indication for neck dissection or cT3/4 and indication for neck dissection
- ipsilateral cN0 and non-midline tumour
- bilateral cN0 and midline tumour
- ipsilateral cN1 and contralateral cN0 with midline tumour
cN0 has to be proven preoperatively by CT, NMR or Ultrasound.
Depending on clinical importance patients with relapse or former operation or radiation might be included.

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Exclusion Criteria

- pregnancy / lactation
- severe psychiatric disease
- no possible formal consent
- missing formal consent
- relapse and former operation
- allergic reaction against Tc-99m-nanocoll

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Addresses

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    • Universitätsklinikum Würzburg
    • Josef-Schneider-Str.
    • 97080  Würzburg
    • Germany
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    • Klinik und Poliklinik für Mund-, Kiefer- und Plastische GesichtschirurgieZentrum für Zahn-, Mund- und KiefergesundheitUniversitätsklinikum Würzburg
    • Mr.  PD Dr. Dr.  Urs  Müller-Richter 
    • Pleicherwall 2
    • 97070  Würzburg
    • Germany
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    • Klinik und Poliklinik für Mund-, Kiefer- und Plastische GesichtschirurgieZentrum für Zahn-, Mund- und KiefergesundheitUniversitätsklinikum Würzburg
    • Mr.  PD Dr. Dr.  Urs  Müller-Richter 
    • Pleicherwall 2
    • 97070  Würzburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Würzburg
    • Josef-Schneider-Str.
    • 97080  Würzburg
    • Germany
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Status

  •   Recruiting planned
  •   [---]*
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Trial Publications, Results and other Documents

  •   Medline
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* This entry means the parameter is not applicable or has not been set.