Radboudumc
Nijmegen, Gelderland, 6500 HB, Netherlands
NCT Number: NCT04068636
This study explores the feasibility of sentinel lymph node identification in pharynx and larynx cancers using flexible endoscopy-guided tracer injection.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Nijmegen, Gelderland, 6500 HB, Netherlands
The presence of lymph node metastases has a large impact on prognosis and treatment in head-and neck cancer (HNC) patients and necessitates treatment intensification. However, despite increased spatial resolution of current imaging techniques, around 20% of patients with a pre-operative clinically negative neck will have occult metastases in the neck dissection specimen. It is therefore that, when patients are treated with radiotherapy, the neck is almost always included in the target volume, also when the tumor is clinically staged N0 (elective neck treatment). As a consequence, large tissue volumes must be treated resulting in significant morbidity such as mucositis, dysphagia, xerostomia and on the long term also hypothyroidism and vascular damage.
If the detection of small lymph node metastases can be improved elective neck treatment may be avoided in at least part of the patients resulting in less toxicity and improved quality of life. One promising approach is the sentinel node procedure. Thus far, the sentinel node procedure is not employed in patients with larynx and pharynx cancers that are treated with primary radiotherapy. One reason is that these tumors are not easily accessible for tracer injection and this needs to be done under general anesthesia. However, in the past few years there has been progress with instrumentation via flexible endoscopy. The ENT-department of Radboudumc has developed expertise with endoscopic biopsy taking and even laser surgery of pharynx and larynx cancers.
The purpose of this study is to explore the feasibility of sentinel lymph node identification in pharynx and larynx cancers using flexible endoscopy-guided tracer injection.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Flexible endoscopy will be performed by one of two experienced head and neck surgeons. Inspection of larynx and pharynx will be performed to determine the extensions of the tumor in all directions. After local anesthesia, 2-4 peritumoral injections of Tc-99m-nanocolloïd will be given. Ten minutes after injection of Tc-99m-nanocolloïd a SPECT scan will be performed.
Time frame: The data of each patient will be assessed within 6 months.
All SPECT images will be assessed qualitatively by concerted consensus between a nuclear medicine physician, head and neck surgeons and a radiation oncologist. Aspects that will be evaluated include:
Time frame: The data of each patient will be assesses within 6 months.
The procedure will be documented on video and will be reviewed by the investigational team for accuracy of tracer injections and learning purposes.
Time frame: The data of each patient will be assesses within 6 months.
All SPECT and CT or MR images will be assessed qualitatively by concerted consensus between a nuclear medicine physician, head and neck surgeons and a radiation oncologist. For this outcome measure the following aspect is visually evaluated: can the lymph nodes identified as sentinel nodes by SPECT also be localized on routine diagnostic imaging (CT, MRI, ultrasound)?
Radboud University Medical Center
Other
Sentinel Node Localization in Larynx and Pharynx Cancers After Flexible Endoscopy-guided Tracer Injection: a Feasibility Study.
Acronym: FLEX-NODE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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