Sentinel Node in Larynx and Pharynx Cancers

NCT04068636 | Completed

• 1 other identifier: FLEX-NODE
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Head and Neck Cancer; Lymph Node Metastases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Feasibility of administering at least 2 peritumoral Tc-99m-nanocolloid injections during one procedure of flexible endoscopy.

  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.

  The data of each patient will be assesses within 6 months.

Study Arms (1)

Flexible endoscopy guided SNB in larynx and pharynx cancers.

EXPERIMENTAL

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.

Interventions

Radioactive tracer injection via flexible endoscopy and SPECT scan for visualization of lymph nodes. PROCEDURE

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.

Flexible endoscopy guided SNB in larynx and pharynx cancers.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboudumc

Nijmegen, Gelderland, 6500 HB, Netherlands

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Lymphatic Metastasis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hans Kaanders, MD, PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2019
• First Posted: August 28, 2019
• Study Start: March 9, 2020
• Primary Completion: January 11, 2022
• Study Completion: January 11, 2022
• Last Updated: April 29, 2022

Record last verified: 2022-04

Locations

NL (1)