Sentinel Node in Larynx and Pharynx Cancers (FLEX-NODE)

Sentinel Node Localization in Larynx and Pharynx Cancers After Flexible Endoscopy-guided Tracer Injection: a Feasibility Study.

This study explores the feasibility of sentinel lymph node identification in pharynx and larynx cancers using flexible endoscopy-guided tracer injection.

Study Overview

• Status: Completed
• Conditions: Head and Neck Cancer; Lymph Node Metastases
• Intervention / Treatment: Procedure: Radioactive tracer injection via flexible endoscopy and SPECT scan for visualization of lymph nodes.

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6500 HB
      • Radboudumc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female aged >18 years.
• Mucosal tumor of the oropharynx, hypopharynx or larynx.
• Patients planned to undergo biopsy via flexible endoscopy.
• Patients planned to undergo curative radiotherapy with or without concurrent chemotherapy.
• Patient provided written informed consent.

Exclusion Criteria:

• Patients who underwent previous surgery or radiotherapy to the neck.
• Patients with airway obstruction causing stridor.
• Prior allergic reaction to Tc-99m-nanocolloïd.
• Pregnancy.
• Unable to provide informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Flexible endoscopy guided SNB in larynx and pharynx cancers.; Patients with larynx and pharynx cancers will undergo sentinel node biopsy via flexible endoscopy. In this procedure, a radioactive tracer will be injected at 2-4 sites edging the tumor. A SPECT scan will be performed for visualization of the sentinel node(s).

Procedure: Radioactive tracer injection via flexible endoscopy and SPECT scan for visualization of lymph nodes.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Generation of SPECT-images of sufficient quality for localization of the sentinel node(s) after peritumoral Tc-99m-nanocolloid injection guided by flexible endoscopy.	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: Is there sufficient uptake of tracer for identification and localization of lymph nodes?; Does tracer uptake in primary tumor interfere with lymph node identification?; Is sentinel lymph node localization consistent with what can be expected with normal, undisturbed lymph node drainage and what is known from the literature?	The data of each patient will be assessed within 6 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of administering at least 2 peritumoral Tc-99m-nanocolloid injections during one procedure of flexible endoscopy.	The procedure will be documented on video and will be reviewed by the investigational team for accuracy of tracer injections and learning purposes.	The data of each patient will be assesses within 6 months.
Comparison between sentinel nodes identified by SPECT and sentinel nodes identified by routine CT or MRI.	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)?	The data of each patient will be assesses within 6 months.

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Investigators: Principal Investigator: Hans Kaanders, MD, PhD, Radboud University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2020
• Primary Completion (Actual): January 11, 2022
• Study Completion (Actual): January 11, 2022

Study Registration Dates

• First Submitted: August 8, 2019
• First Submitted That Met QC Criteria: August 22, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Actual): April 29, 2022
• Last Update Submitted That Met QC Criteria: April 27, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplasms by Site; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Neoplastic Processes; Neoplasm Metastasis; Lymphatic Metastasis; Pharyngeal Neoplasms
• Other Study ID Numbers: FLEX-NODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No