Condition category
Cancer
Date applied
04/01/2019
Date assigned
06/02/2019
Last edited
06/02/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Public

Primary contact

Dr Nicolas Dulguerov

ORCID ID

http://orcid.org/0000-0001-8676-3698

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CER 13-217

Study information

Scientific title

Sentimag and MRI interstitial lymphangiography in Head and Neck cancer Sentinel Node Biopsy

Acronym

Study hypothesis

Our hypothesis is that Sentinel lymph node can be accurately identified with a small iron oxide particle (SPIO).

Ethics approval

Ethical committee for research on human subjects, 07/01/2014, ref. CER:13-217.

Study design

Interventional, non-randomised, single-centre

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

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

Phase

Drug names

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 trial start date

01/01/2012

Overall trial end date

31/12/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Diagnosed with a new cN0 HNSCC within the oral cavity and oropharynx
2. Multi-disciplinary tumor board proposal is surgical treatment.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

24

Participant 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

Recruitment start date

07/01/2014

Recruitment end date

04/09/2018

Locations

Countries of recruitment

Switzerland

Trial 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

Organisation

Geneva University Hospital

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

https://www.hug-ge.ch/

Funders

Funder type

Hospital/treatment centre

Funder name

Dpt of Otorhinolaryngology and Head and Neck surgery

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Results publication 1st trimester 2019

IPD sharing statement: the datasets generated during the current study will be included in the subsequent results publication.

Intention to publish date

01/03/2019

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes