|- candidate number||22209|
|- NTR Number||NTR5219|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||18-mei-2015|
|- Secondary IDs||N14LMN |
|- Public Title||Analyse van de lymfatische drainage in de hals bij mondholte tumoren door het gebruik van ICG-nanocolloid. |
|- Scientific Title||Lymphatic mapping of the neck in oral cavity malignancies using ICG-nanocolloid|
|- ACRONYM||Oral cavity lymphatic mapping using ICG-nanocolloid|
|- hypothesis||Via a peritumoral injection of ICG-nanocolloid, lymphatic mapping of oral cavity tumors can be performed|
|- Healt Condition(s) or Problem(s) studied||Squamous cell carcinoma of the head and neck (SSCHN), Oral Squamous Cell Carcinoma (OSCC), Head and Neck Squamous Cell Carcinoma|
|- 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.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-jul-2015|
|- planned closingdate||1-jul-2017|
|- Target number of participants||40|
|- Interventions||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.|
|- 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.
|- Timepoints||One timepoint, directly after excision of the neck dissection specimen fluorescent lymph nodes will be identified|
|- Trial web site||TRION|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MD, PhD
W. Martin C.
|- CONTACT for SCIENTIFIC QUERIES|| FWB van Leeuwen|
|- Sponsor/Initiator ||Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital (NKI AVL) |
(Source(s) of Monetary or Material Support)
|Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital (NKI/AVL), NWO-STW-VIDI (Grant No. STW BGT11272) , ERC-starting Grant (Grant No. 2012-306890)|
|- Brief 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.
|- Main changes (audit trail)|
|- RECORD||18-mei-2015 - 29-jul-2015|