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Sentinel lymph node localization of oral cancer using magnetic detection.


- candidate number28312
- NTR NumberNTR6890
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-dec-2017
- Secondary IDsMETC Twente P17-23, NL63042.044.17  STW-KWF/NWO 15194
- Public TitleSentinel lymph node localization of oral cancer using magnetic detection.
- Scientific TitleDetection of the sentinel lymph node in oral cancer using iron oxide nanoparticles, MRI and a magnetometer: a pilot study.
- ACRONYMMagLocHN
- hypothesisSentinel 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.
- Healt Condition(s) or Problem(s) studiedSentinel Lymph Node Biopsy (SLNB), Oral cavity, Cancer, Magnetic detection
- Inclusion criteria- Patients diagnosed with T1-T2 oral cancer scheduled for END and who are clinically and radiologically node negative (cN0);
- 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;
- Intolerance/ hypersensitivity to iron or dextran compounds or Sienna+;
- Patients with an iron overload disease;
- Patients with non-palpable malignancies;
- Pregnant patients;
- Patients with pacemakers or other implantable devices in the upper body.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-jan-2018
- planned closingdate31-dec-2018
- Target number of participants10
- InterventionsPeritumoral injection of SPIO 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.
- Primary outcomeTo 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.
- TimepointsWhen 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.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMSc E.R. Nieuwenhuis
- CONTACT for SCIENTIFIC QUERIESMSc E.R. Nieuwenhuis
- Sponsor/Initiator University of Twente
- Funding
(Source(s) of Monetary or Material Support)
STW, KWF Kankerbestrijding
- Publications
- Brief summarySentinel 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.
- Main changes (audit trail)
- RECORD6-dec-2017 - 26-jan-2018


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