No registrations found.
ID
Source
Brief title
Health condition
Sentinel node biopsy (SNB), sentinel lymph node (SLN), oral cancer, magnetic detection.
DUTCH: poortwachterklier procedure, mondholte kanker, magnetische detectie
Sponsors and support
Intervention
Outcome measures
Primary outcome
To investigate the feasibility of the magnetic approach in detection of the SLNs during SNB in the neck of patients with T1-T2 cancer
Secondary outcome
- Detectionrate
- Compare results of MRI, surgery and pathology.
Background summary
Sentinel node biopsy (SNB) is a highly sensitive procedure for lymph node (LN) staging in head and neck cancer, particularly in T1-T2 oral cancer patients (1). However, nowadays sentinel lymph nodes (SLN, lymph nodes with the highest risk for containing metastasis) cannot always be detected by currently available radioactive tracer due to the complex head and neck anatomy and the ‘shine through’ phenomenon of radioactive tracers due to the close spatial relation with the primary tumor, e.g. floor of mouth. Magnetic tracers may overcome the problems of currently used (radioactive) tracers. The feasibility of magnetic SLN detection in head and neck cancer patients, is tested with a first-generation magnetic detector. The magnetic application to SNB enables more reliable staging and patient friendly and highly personalized treatment by eliminating the need to surgically remove all LNs in this region in all patients (2).
1. Govers TM, Hannink G, Merkx MAW, Takes RP, Rovers MM. Sentinel node biopsy for squamous cell carcinoma of the oral cavity and oropharynx:
A diagnostic meta-analysis. Oral Oncol. Elsevier Ltd; 2013;49(8):726–32.
2. Murer K, Huber G, Haile S, Stoeckli S. Comparison of morbidity between sentinel node biopsy and elective neck dissection for treatment of the n0 neck in patients with oral squamous cell carcinoma. Head Neck. 2011;33(9):1260–4.
Study objective
Sentinel node biopsy (SNB) is a highly sensitive procedure for lymph node (LN) staging in head and neck cancer, particularly in T1-T2 oral cancer patients. However, nowadays sentinel lymph nodes (SLN, lymph nodes with the highest risk for containing metastasis) cannot always be detected by currently available radioactive tracer due to the complex head and neck anatomy and the ‘shine through’ phenomenon of radioactive tracers due to the close spatial relation with the primary tumor, e.g. floor of mouth. Magnetic tracers (superparamagnetic nano particles, SPIO) may overcome the problems of currently used (radioactive) tracers. The feasibility of magnetic SLN detection in head and neck cancer patients, is tested with a first-generation magnetic detector. The magnetic application to SNB enables more reliable staging and patient friendly and highly personalized treatment by eliminating the need to surgically remove all LNs in this region in all patients.
Study design
When the first 5 inclusions are finished results of the post-op MRI will be analyzed and determine if SPIO dose needs to be adjusted and if upcoming inclusions also need an post-op MRI.
Intervention
Peritumoral injection of SPIO, after Xillocaïne spray, and followed by an MRI to localize the SLN, the day before surgery. Also trancutaneous detection of trapped SPIO in SLN will be performed using a magnetometer.
At the day of surgery a SNB is performed during standard elective neck dissection. The SLN will be intraoperatively detected using a magnetometer.
Four-six weeks after surgery an extra MRI might be made.
E.R. Nieuwenhuis
P.O. Box 217
[default]
The Netherlands
+31534891351
e.r.nieuwenhuis@utwente.nl
E.R. Nieuwenhuis
P.O. Box 217
[default]
The Netherlands
+31534891351
e.r.nieuwenhuis@utwente.nl
Inclusion criteria
- Patients diagnosed with T1-T2 oral cancer scheduled for END and who have clinically and radiologically at maximum cN1, <15mm and not contains necrotic tissue;
- Willing to & able to write informed consent from the subject prior to participation.
- Willing to & capable of following study procedures
- Is older than 18 years
- Speaks and understand the Dutch language
Exclusion criteria
- Positive result of ultrasound fine needle aspiration, for nodes >15mm and/or necrotic tissue;
- Intolerance/ hypersensitivity to iron or dextran compounds or Sienna+;
- Intolerance/ hypersensitivity to lidocaine;
- Patients with an iron overload disease;
- Patients with non-palpable malignancies;
- Pregnant patients;
- Patients with pacemakers or other implantable devices in the upper body.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL6656 |
| NTR-old | NTR6890 |
| Other | STW-KWF/NWO 15194 : METC Twente P17-23, NL63042.044.17 |