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…
ID
Bron
Verkorte titel
Aandoening
Sentinel node biopsy (SNB), sentinel lymph node (SLN), oral cancer, magnetic detection.
DUTCH: poortwachterklier procedure, mondholte kanker, magnetische detectie
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
To investigate the feasibility of the magnetic approach in detection of the SLNs during SNB in the neck of patients with T1-T2 cancer
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
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.
Onderzoeksproduct en/of interventie
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.
Publiek
E.R. Nieuwenhuis
P.O. Box 217
[default]
The Netherlands
+31534891351
e.r.nieuwenhuis@utwente.nl
Wetenschappelijk
E.R. Nieuwenhuis
P.O. Box 217
[default]
The Netherlands
+31534891351
e.r.nieuwenhuis@utwente.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL6656 |
| NTR-old | NTR6890 |
| Ander register | STW-KWF/NWO 15194 : METC Twente P17-23, NL63042.044.17 |