Sentinel node biopsy in head and neck cancer: development of a new technique

Not Applicable

Completed

• Conditions: Head and Neck cancer; Cancer

• Registration Number: ISRCTN44750045
• Lead Sponsor: Geneva University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-12-31
• Study Start: 2019-02-06
• Last Update Posted: 4 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. Diagnosed with a new cN0 HNSCC within the oral cavity and oropharynx
2. Multi-disciplinary tumor board proposal is surgical treatment.

Exclusion Criteria

1. Age below 18 years old at the time of diagnosis
2. Pregnancy
3. Previous Head and Neck cancer
4. Other cancer in the last two years (other than non-melanoma skin cancer)
5. Previous neck radiotherapy
6. Contra-indication to magnetic resonance Imaging (pacemeaker, cerebral metallic implant, claustrophobia)
7. Overload iron disease
8. Allergy to dextran

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation of nodal staging with Sentimag® guided SLNB and the nodal staging by the completion neck dissection .

Secondary Outcome Measures

Name	Time	Method
<br> 1. Identification of the SPION tracer in the SLN with pre-operative T2* MRI<br> 2. Per-operative identification of the SLN with Sentimag®-guidance<br> 3. Histopathological detection of the SPION in the SLN and in the remaining nodes within the completion neck dissection.<br>