PET-CT lymphoscintigraphy for sentinel node detection in head and neck cancer: a feasibility study
Completed
- Conditions
- head and neck cancerhead and neck squamous cell carcinoma10027476
- Registration Number
- NL-OMON39155
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
Inclusion Criteria
* Early stage oral cavity carcinoma (T1-2, cN0) scheduled for transoral excision and sentinel node procedure (Part A)
* Oral cavity carcinoma (maximum tumor size 4 cm) which are scheduled for more extensive surgery including neck dissection, e.g. for patients with proven lymph node metastases (max. N1 disease) or patients in which the primary tumor cannot be resected transorally and for which the neck is opened for reconstruction purposes (Part B)
* Age>18 years
* Previously untreated
* Written informed consent
Exclusion Criteria
1. presence of nodal disease in the neck (PART A);2. prior treated by radiotherapy, chemotherapy, or surgery in the head and neck area;3. pregnancy
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>identification rate of sentinel nodes as depicted by PET-CT compared to<br /><br>conventional planar lymphoscintigraphy. (PART A)<br /><br>Evaluation of intraoperative detection of 89Zr-Nanocoll containing lymph nodes<br /><br>using a PET-probe. (PART B)</p><br>
- Secondary Outcome Measures
Name Time Method <p>-number and localisation of sentinel nodes on both imaging modalities (PET-CT<br /><br>and conventional)<br /><br>-additional value of PET-CT<br /><br>-evaluation of PET-probe guided detection and resection of sentinel nodes</p><br>