3D-based Sentinel Lymph Node Diagnosis and Biopsy in Head and Neck Cancer
Not Applicable
- Conditions
- C01C02C03C04C05Malignant neoplasm of lipMalignant neoplasm of base of tongueMalignant neoplasm of other and unspecified parts of tongueMalignant neoplasm of gumMalignant neoplasm of floor of mouth
- Registration Number
- DRKS00007719
- Lead Sponsor
- niversitätsklinikum Würzburg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 30
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.
Exclusion Criteria
- pregnancy / lactation
- severe psychiatric disease
- no possible formal consent
- missing formal consent
- relapse and former operation
- allergic reaction against Tc-99m-nanocoll
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method 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.