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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04068636
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : March 16, 2020
Sponsor:
Information provided by (Responsible Party):
Radboud University

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

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Lymph Node Metastases Procedure: Radioactive tracer injection via flexible endoscopy and SPECT scan for visualization of lymph nodes. Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Sentinel Node Localization in Larynx and Pharynx Cancers After Flexible Endoscopy-guided Tracer Injection: a Feasibility Study.
Estimated Study Start Date : March 9, 2020
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

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.




Primary Outcome Measures :
  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. [ 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:

    • 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?


Secondary Outcome Measures :
  1. Feasibility of administering at least 2 peritumoral Tc-99m-nanocolloid injections during one procedure of flexible endoscopy. [ 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.

  2. Comparison between sentinel nodes identified by SPECT and sentinel nodes identified by routine CT or MRI. [ 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)?



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04068636


Contacts
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Contact: Daphne AJ Driessen, MD +31950008371 daphne.driessen@radboudumc.nl

Locations
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Netherlands
Radboudumc Recruiting
Nijmegen, Gelderland, Netherlands, 6500 HB
Contact: Daphne Driessen, Msc    +31650008371    daphne.driessen@radboudumc.nl   
Sponsors and Collaborators
Radboud University
Investigators
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Principal Investigator: Hans Kaanders, MD, PhD Radboud University
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Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT04068636    
Other Study ID Numbers: FLEX-NODE
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: March 16, 2020
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pharyngeal Neoplasms
Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases