C00 C01 C02 C03 C04 C05
Conditions
Interventions
Group 1: 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.
Gro
Sponsors
Universitätsklinikum Würzburg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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
Exclusion criteria: - pregnancy / lactation - severe psychiatric disease - no possible formal consent - missing formal consent - relapse and former operation - allergic reaction against Tc-99m-nanocoll
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Germany
Contacts
Public ContactUrs Müller-Richter
Klinik und Poliklinik für Mund-, Kiefer- und Plastische GesichtschirurgieZentrum für Zahn-, Mund- und KiefergesundheitUniversitätsklinikum Würzburg
Outcome results
None listed