Determining the feasibility of SLN detection in the neck of oral cancer patients using a magnetic tracer (Sienna+®), MRI and hand-held magnetometer (SentiMag®).When the magnetic approach of sentinel node detection is found to be feasible, the main…
ID
Source
Brief title
Condition
- Head and neck therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
* The proportion of patients in which the SLNs could be detected (detection
rate) using the magnetic method.
* The proportion of sentinel nodes detected per patient during the SNB (in
vivo) and after END, thus excised specimen (ex vivo).
* The false-negative rate of detected SLNs based on the histopathological
analysis.
Secondary outcome
* The proportion of sentinel nodes which could be localized per patient on the
MRI;
* Estimation of maximal distance needed to detect Sienna signal by SentiMag;
* SNB duration/ total duration time.
Background summary
The sentinel node biopsy (SNB) is a minimal invasive procedure to evaluate the
occurrence of occult metastases for tumors that metastasize via the lymphatic
system. Within the standard SNB procedure, a radioactive tracer is used for
localization and detection of sentinel lymph nodes (SLNs). Unlike in breast
cancer and melanoma, an accurate method for nodal staging is not available for
all cancer (sub)types of which head and neck cancer is one of the most complex
types. There is a need to find another tracer/ route which has a better
sensitivity in localization and detection of floor of mouth-tumors.
For the SNB procedure in the axilla (breast cancer), good results were found
with the use of a magnetic route (SentiMag®, magnetic detector, and Sienna+®,
magnetic tracer).
In the IronNanoLoc program, we aim to develop a patient friendly and reliable
procedure for SLN detection and staging for a patient group that presently
cannot fully benefit from such a high-quality SLN-biopsy procedure, that is
much less invasive than the END that is presently used in this H&N patient
group. The first step in the IronNanoLoc program is to start with a pilot study
to test the feasibility of the magnetic route, using SentiMag® and Sienna+®. If
it*s shown feasible, research will be done to improve the magnetic approach and
the radioactive and magnetic route will be compared in a subsequent study.
Study objective
Determining the feasibility of SLN detection in the neck of oral cancer
patients using a magnetic tracer (Sienna+®), MRI and hand-held magnetometer
(SentiMag®).
When the magnetic approach of sentinel node detection is found to be feasible,
the main study will be performed. In this main study, the conventional SNB and
the magnetic approach for SNB in the head and neck area are compared.
Study design
An interventional, minimally invasive pilot study embedded in standard patient
care (elective neck dissection (END)).
Intervention
A peritumoral injection with magnetic/ iron oxide nanoparticles (Sienna+) is
given, followed by an pre-operative MRI to localize the SLN. During elective
neck dissection (standard care), an additional SNB is performed using a
hand-held magnetometer (SentiMag®) and the already injected Sienna+. Surgery
will be completed following standard care (elective neck dissection and tumor
resection).
Study burden and risks
Burden: Additional local interstitial injection with magnetic tracer (Sienna+).
Additional MRI-scan pre-operative and post-operative. Risks & benefits: no
risks and benefits are expected for the participants, after the SNB, elective
neck dissection will be completed and the magnetic tracer is dissected too, so
participants finally undergo standard care and treatment is not delayed by the
study. A relative prolongation of operation room time is expected, however due
to finally given standard care, operation risks are not increased.
It is important to perform the study in patients with oral cancer, to see if
the magnetic application is feasible for detection of SLN in the neck and can
overcome the shortcomings of the conventional SNB in this patient group.
Therefore, benefits of the magnetic SLN detection are concerning the future
patient group, for reliable staging and patient friendly and highly
personalized treatment by eliminating the need to surgically remove all LNs in
this region in all patients.
Drienerlolaan 5
Enschede 7522 NB
NL
Drienerlolaan 5
Enschede 7522 NB
NL
Listed location countries
Age
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
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL63042.044.17 |