Mapping of Sentinel lymph node drainage Using SPECT to tailor highly-selective elective nodal irradiation in node-negative neck of patients with head and neck cancer (SUSPECT)

Although considerable gains have been achieved over the last few decades with
regard to loco-regional control (LRC) and overall survival (OS) in patients
with head and neck cancer (HNC), the incidence of radiation-related toxic¬ity
remains high, obviously because of the radiation damage to the salivary glands,
mucosal area, swallowing and chewing muscles and structures involved in
voicing and articulation. Despite the introduction of new highly-conformal
radiation techniques the rate of these side effects remains high, mostly
because of the large irradiated volumes, for instance because of bilateral neck
irradiation.

This study aims to explore the feasibility, safety and outcome of a
non-invasive sentinel node mapping (SNM) to individually tailor the elective
nodal irradiation (ENI) to the ipsilateral neck only and to exclude the
contralateral negative neck from the irradiation fields when there is no
draining sentinel node. Subsequently the dose to the salivary glands, mucosal
area and the swallowing and chewing muscles and structures involved in voicing
and articulation will significantly be reduced.

The aim of the study is to investigate the feasibility, safety, toxicity,
quality of life (QoL), and regional control of unilateral ENI using SNM with
SPECT/CT to select patients with unilateral drainage in lateralized HNSCC
treated with primary radiotherapy or chemoradiation.

This study will be a single center phase II study. The duration of the study
will be 36 months, with an inclusion rate of at least 1 patient per month. Each
patient has a follow-up for 5 years (standard of care)

SPECT/CT scan. Injection of Technetium-99m-nanocolloid (as a radioactive
tracer) will be performed during the routine endoscopy under general anesthesia

In patients participating in the study, radioactive Tc-Albumin (Nanocolloid),
as radioactiver tracer, will be injected submucosally around the tumor.
Subsequently, SPECT/CT will be performed to identify the draining lymph nodes
in order to tailor the neck levels to be treated electively, trying to exclude
the elective irradiation of the contralateral clinically negative neck. The use
of SPECT/CT for the SNM will tailor the ENI to highly selective levels when
unilateral drainage is present. This approach has, therefore, the potential to
reduce the radiation dose to different organs at risk, such as salivary glands,
mucosal area and the swallowing and chewing muscles and the structures involved
in voicing and articulation and subsequently the incidence of different
troublesome radiation-induced side effects such as xerostomia, dysphagia and
trismus, significantly affecting patients* quality of life. The radiation
burden is estimated at 0,8 mSv from the radiopharmaceutical (0,01 mSv/MBq) and
1 mSv from low dose CT of the neck, for a total of about 2 mSv for the complete
procedure. This is in the range of routine clinical diagnostic procedures.
Allergic reactions or other adverse reactions have not been described. There
will be no additional invasive procedures. Thus, the procedure is considered
safe and well-tolerable by the selected patient group.