C30.0 C31
Conditions
Interventions
Group 1: • Preoperative lymphoscintigraphy with radiocolloids within 24 hours before surgery, visualisation of SLN by SPECT-CT
• Resection of primary tumor and gamma probe guided SNB
Sponsors
Universitätsklinikum Ulm, Kliniken am oberen Eselsberg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Histologically proven malignancy of the nasal vestibulum and the sinonasal tract; T1-3, N0, M0; squamous cell carcinoma • Primary tumor must be resectable endoscopically or via limited open approach without changing the facial appearance • Written and signed informed consent • ECOG PS =2, Karnofsky PS = 60 % • Age = 18 • Curative treatment intent
Exclusion criteria
Exclusion criteria: • Prior head and neck malignancy • Entity other than squamous cell carcinoma • Clinically suspected lymph node or distant metastases • Serious co-morbidity, e.g. high-grade carotid artery stenosis, congestive heart failure NYHA grade 3 and 4, liver cirrhosis CHILD C • Hemoglobin level < 9.5 g/dl • Pregnancy or lactation • Prior treatment of the neck of any cause • Concurrent treatment with experimental drugs or participation in another clinical trial of any kind within 30 days prior to study screening • Social situations that limit compliance with study requirements or patients with an unstable condition (e.g., psychiatric disorder, a recent history of drug or alcohol abuse, interfering with study compliance, within 6 months prior to screening) or otherwise thought to be unreliable or incapable of complying with the requirements of the protocol • Patients institutionalized by official means or court order
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Surgical morbidity, Lymph node metastasis detection rate by sentinel node biopsy, Duration of hospitalization, Feasibility of PET/MR scan before surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to regional metastasis, Time to death of any cause, Time to distant metastasis, Concordance of PET/MR positive and sentinel lymph nodes, Prognostic value of PET/MR data. Follow-up will be up to 5 years. | — |
Countries
Germany
Contacts
Public ContactAdrian von Witzleben
Klinik für Hals-Nasen-Ohrenheilkunde, Kopf- und Halschirurgie, Universitätsklinikum Ulm
Outcome results
None listed