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

ISRCTN	ISRCTN44750045
DOI	https://doi.org/10.1186/ISRCTN44750045
Secondary identifying numbers	CER 13-217

Submission date: 04/01/2019
Registration date: 06/02/2019
Last edited: 06/02/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Early stage (T1-T2) squamous cell carcinoma of the oral cavity with clinically N0 neck is associated with a false-negative rate of 40% for neck metastasis. As neck metastasis is the main predictive factor in head and neck cancer, it is of paramount importance to stage those patients accurately in order to offer them the best chance of survival. Sentinel lymph node (SLN) biopsy is a minimally invasive procedure which is validated in the evaluation of the presence of occult neck metastasis. We present an original technique, using a small iron oxide nanoparticles (SPIO) dextran coated of 60 nm as a tracer and detected per-operatively with Sentimag. The SPIO offer the additional advantages of being detected in the lymph nodes during the pathologic exam, establishing a positive control in the identification of the correct SLN, and, of being traceable during the magnetic resonance imaging. Last, it is not radioactive, facilitating its use in routine practice.

The primary outcome is the correlation of nodal staging with Sentimag-guided SLNB with the nodal staging by the completion neck dissection.

Who can participate?
Any patient with a new cN0 HNSCC within the oral cavity and oropharynx for which the multi-disciplinary tumor board proposal is surgical treatment.

What does the study involve?
Small iron oxide nanoparticles are injected around the tumor before the patient undergoes tumor resection and a neck dissection. Before doing the neck dissection we identify the sentinel lymphnode percutaneously with a probe called Sentimag. If found, we excise it and send it separately for pathology exam. The rest of the neck dissection is performed as usual. The patient is the woken up and the rest of the recovery and follow-up is as per standards.

What are the possible benefits and risks of participating?
There are no particular benefit for the patient except for the thorough pathological examination of the SLNB with multi level slices. Risks are limited except for side effects of the SPIO (allergy) and the discomfort of the peritumoral injection.

Where is the study run from?
Geneva University Hospital

When is the study starting and how long is it expected to run for?
January 2012 until December 2018

Who is funding the study?
Geneva University Hospital

Who is the main contact?
Dr Nicolas Dulguerov
Nicolas.Dulguerov@hcuge.ch

Contact information

Dr Nicolas Dulguerov
Public

Dpt of Otorhinolaryngology and Head and Neck surgery
Clinical Neurosciences
4, rue Gabrielle-Perret-Gentil
Geneva
1211 Geneva 14
Switzerland

ORCID ID	0000-0001-8676-3698

Study information

Study design	Interventional, non-randomised, single-centre
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet.
Scientific title	Sentimag and MRI interstitial lymphangiography in Head and Neck cancer Sentinel Node Biopsy
Study objectives	Our hypothesis is that Sentinel lymph node can be accurately identified with a small iron oxide particle (SPIO).
Ethics approval(s)	Ethical committee for research on human subjects, 07/01/2014, ref. CER:13-217.
Health condition(s) or problem(s) studied	Head and Neck cancer
Intervention	The intervention involves injecting a small iron oxide nanoparticles around the tumor. Then, the patient is taken to theater to undergo tumor resection and a neck dissection. Before doing the neck dissection we identify the sentinel lymphnode percutaneously with a probe called Sentimag. If founded, we excise it and send it separately for pathology exam. The rest of the neck dissection is performed as usual. The patient is the woken up and the rest of the recovery and follow-up is as per standards.
Intervention type	Procedure/Surgery
Primary outcome measure	Correlation of nodal staging with Sentimag® guided SLNB and the nodal staging by the completion neck dissection .
Secondary outcome measures	1. Identification of the SPION tracer in the SLN with pre-operative T2* MRI 2. Per-operative identification of the SLN with Sentimag®-guidance 3. Histopathological detection of the SPION in the SLN and in the remaining nodes within the completion neck dissection.
Overall study start date	01/01/2012
Completion date	31/12/2018

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	24
Key inclusion criteria	1. Diagnosed with a new cN0 HNSCC within the oral cavity and oropharynx 2. Multi-disciplinary tumor board proposal is surgical treatment.
Key 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
Date of first enrolment	07/01/2014
Date of final enrolment	04/09/2018

Locations

Countries of recruitment

Switzerland

Study participating centre

Geneva University Hospital

Dpt of Otorhinolaryngology and Head and Neck surgery
Clinical Neurosciences
4, rue Gabrielle-Perret-Gentil
Geneva
1211 Geneva 14
Switzerland

Sponsor information

Geneva University Hospital
Hospital/treatment centre

Dpt of Otorhinolaryngology and Head and Neck surgery
Clinical Neurosciences
4, rue Gabrielle-Perret-Gentil
Geneva
1211 Geneva 14
Switzerland

Website	https://www.hug-ge.ch/
"ROR"	https://ror.org/01m1pv723

Funders

Funder type

Hospital/treatment centre

Dpt of Otorhinolaryngology and Head and Neck surgery

No information available

Results and Publications

Intention to publish date	01/03/2019
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Other
Publication and dissemination plan	Results publication 1st trimester 2019
IPD sharing plan	The datasets generated during the current study will be included in the subsequent results publication.