To analyze the value of lymphatic mapping in HNSCC patients with a previously treated neck.
ID
Source
Brief title
Condition
- Respiratory and mediastinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint is the lymph node drainage of recurrent or second primary
HNSCC in the previously treated neck.
Secondary outcome
Secondary endpoints are alteration of lymphatic drainage after previous
treatment of the neck and influence of lymph node mapping (and sentinel node
biopsy or cytology) on treatment planning.
Background summary
Treatment of lymph nodes is based on the knowledge that the pattern of
metastatic spread is predictable, and related to site, size and
histopathological status of the primary tumor. However, any disturbance of
normal drainage by operation, radiotherapy or recurrent disease, can result in
other pathways of lymphatic drainage with dissemination of cancer cells.
Lymphoscintigraphy is able to supply a complete map of the lymphatic drainage
and thereby tailoring treatment which may minimise the extent of under- and
overtreatment. If accessible the status of these sentinel lymph nodes can be
determined by histopathological examination of excised sentinel nodes (sentinel
node biopsy procedure) or (ultrasound guided) fine needle aspiration cytology
of these nodes.
Study objective
To analyze the value of lymphatic mapping in HNSCC patients with a previously
treated neck.
Study design
This is an observational non-randomized single-institute pilot study.Injection
of radiolabeled-colloid prior or during anesthesia for endoscopy,
lymphoscintigraphy using a gamma camera and if possible (depending on the
localization) surgical excision of the sentinel lymph node(s) or (ultrasound
guided) fine needle aspiration cytology.
Study burden and risks
Lymphoscintigraphy and sentinel node biopsy and aspiration are procedures which
are used routinely in several tumor types. In the literature on head and neck
cancer no serious adverse events have been reported using these techniques.
Sentinel node biopsy and ultrasound guided fine needle aspiration cytology will
be performed by experienced head and neck surgeons, radiologist and
pathologist.
De Boelelaan 1117
1081 HV
Nederland
De Boelelaan 1117
1081 HV
Nederland
Listed location countries
Age
Inclusion criteria
recurrent or scond primary head and neck cancer
suitable for peritumoral injection
previous treatment of lymph nodes
clinically N0 neck
Exclusion criteria
age <18 or > 80years
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 | NL14237.029.06 |