To accurately differentiate between metastatic and non-metastatic lymph nodes using light reflectance spectroscopy.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Hoofd-halskanker en lymfekliermetastase
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The optical absorption properties of the metastatic and non-metastatic LN.
Secondary outcome
N/A
Background summary
Head and neck squamous cell carcinoma (HNSCC) has a high propensity to
metastasize to cervical lymph nodes (LN). This is associated with a markedly
reduced survival. The management of patients with a clinically negative neck
(cN0) is still a controversial issue. One policy is to surgically treat all
patients with a neck dissection (ND). This prevents occult metastases becoming
advanced but also implies over treating many patients. Another option is to
actively monitor the cN0 neck. The existing techniques to do this, however, all
have limitations in detecting small metastatic deposits. A possible solution
for the management of cN0 necks is to perform a sentinel node biopsy. If the
sentinel node contains malignant cells, a ND is recommend. Currently this ND is
done in a second (staged) procedure as histopathologic examination of the
sentinel node takes time. Single fiber reflectance spectroscopy (SFR) has the
potential to significantly reduce the number of second stage surgery by
in-vivo, immediate detection of metastases in the sentinel node. LN with
metastases undergo physiological changes that can be detected by SFR. A
previous similar study showed very promising results in mediastinal LN in
patients with lung cancer. In this study we would like the first step towards
using SFR to detect metastases in sentinel LN in patients with HNSCC. We will
do this by investigating if SFR can accurately discriminate metastatic cervical
LN from non-metastatic LN.
Study objective
To accurately differentiate between metastatic and non-metastatic lymph nodes
using light reflectance spectroscopy.
Study design
Observational non-randomized cohort study.
Study burden and risks
The spectroscopy measurements will be performed while patients are under
general anesthesia. Measurements will be performed in vivo on tissues that will
be excised regardless of this study. The patients will not benefit from the
study.
Burg. Jacobsplein 51
Rotterdam 3000 CA
NL
Burg. Jacobsplein 51
Rotterdam 3000 CA
NL
Listed location countries
Age
Inclusion criteria
- Diagnosis of a primary head and neck squamous cell carcinoma, all subsites, all TNM-stages
- A indication for a neck dissection
Exclusion criteria
- Prior treatment of the tumor ((chemo)radiation or surgery)
- Age < 18
- No understanding of Dutch language
- Serious other illness
Design
Recruitment
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 | NL61999.078.17 |