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ID
Source
Brief title
Health condition
Oral cavity carcinoma; Squamous cell carcinoma; Head and Neck cancer, Tongue cancer, Floor of mouth cancer
Sponsors and support
NWO-STW-VIDI (Grant No. STW BGT11272)
ERC-starting Grant (Grant No. 2012-306890)
Intervention
Outcome measures
Primary outcome
Lymphatic mapping of the neck in oral cavity malignancies using ICG-nanocolloid.
Secondary outcome
1. Analysis of lymphatic drainage of the head and neck area to determine the extension of the neck dissection.
2. Identification of the tumor draining lymph node(s).
3. In case of lymph node metastasis: Evaluation of the rerouting phenomenon.
Background summary
In 20-30% of the patients with squamous cell carcinoma of the oral cavity who are staged clinically node negative occult metastasis are present. In experienced hands, the most sensitive method of staging the lymph nodes of the neck is ultrasound-guided fine needle aspiration cytology (USgFNAC) with a sensitivity and specificity of 42-98% and 92-100%, respectively. To further improve the sensitivity of occult lymph node metastasis detection, patients with USgFNAC negative lymph nodes are generally scheduled for a sentinel node (SN) biopsy procedure.
The SN is defined as a lymph node receiving direct lymph drainage from the primary tumor. Assuming the orderly spread of tumor cells through the lymphatic system, pathological evaluation of the SN allows accurate determination of the tumor status of the lymph node and therefor the regional lymphatic system.
Some authors have stated that the tumor load of the lymph nodes can influence the drainage route of the radiocolloid through the lymphatic system in such a way that lymph nodes saturated with tumor deviate the drainage pattern. This may ultimately lead to the identification of a different SN than the true tumor-harboring node SN. This phenomenon is called “rerouting”. Another phenomenon that can influence the false-negative rate in are the so-called “skip metastases”. The term “skip metastases” refers to the presence of lymph node metastasis in the lower neck levels (levels III-V) whereas the level I and II lymph nodes (more close to the tumor) are metastasis free. Byers et al. reported that “skip metastases” are present in 16% of tongue carcinoma patients.
Within this study we will investigate the drainage pattern of oral cavity tumors using an intraoperative injection of the colloidal tracer ICG-nanocolloid. Fluorescence imaging of this tracer allows use to study the above-mentioned primary and secondary study aims.
Study objective
Via a peritumoral injection of ICG-nanocolloid, lymphatic mapping of oral cavity tumors can be performed
Study design
One timepoint, directly after excision of the neck dissection specimen fluorescent lymph nodes will be identified
Intervention
Directly before the start of the operation 0.4-0.8 mL ICG-nanocolloid will be injected around the primary tumor. After the therapeutic or elective neck dissection the fluorescent lymph nodes will be excised and photographed. This will be done per cervical level. Fluorescent lymph nodes will be collected separately from the lymph nodes collected with the neck dissection specimen. After completion of the operation, specimens will be sent to the department of pathology for evaluation of the tumor status of the nodes. Fluorescent lymph nodes will be evaluated following the sentinel node protocol. The remainder lymph nodes will be evaluated following the standard protocol.
W. Martin C.
Klop
Plesmanlaan 121
1066 CX
W. Martin C.
Klop
Plesmanlaan 121
1066 CX
Inclusion criteria
Patients ≥ 18 years;
Patients with T1-T4 oral cavity tumor;
Patients scheduled for commando resection or transoral resection with a subsequent elective or therapeutic neck dissection.
Exclusion criteria
Patients who have received prior surgical treatment or radiation therapy to the neck;
Hyperthyroid or thyroidal adenoma;
History of iodine allergy;
Severe kidney insufficiency.
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 |
---|---|
NTR-new | NL5087 |
NTR-old | NTR5219 |
Other | : N14LMN |