Head and Neck CancerFLEX-NODENCT04068636
Sentinel Node in Larynx and Pharynx Cancers
A study testing Radioactive tracer injection via flexible endoscopy and SPECT scan for visualization of lymph nodes. in people with Head and Neck Cancer and Lymph Node Metastases, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
This study explores the feasibility of sentinel lymph node identification in pharynx and larynx cancers using flexible endoscopy-guided tracer injection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Lymph Node Metastases
- What is being tested?
- Radioactive tracer injection via flexible endoscopy and SPECT scan for visualization of lymph nodes.
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteNetherlands
- Study dates
- 9 Mar 2020to 11 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Head and Neck Cancer, Lymph Node Metastases
- Being tested
- Radioactive tracer injection via flexible endoscopy and SPECT scan for visualization of lymph nodes.
- Medical subject headings
- Head and Neck Neoplasms, Lymphatic Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radioactive tracer injection via flexible endoscopy and SPECT scan for visualization of lymph nodes.Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Procedure: Radioactive tracer injection via flexible endoscopy and SPECT scan for visualization of lymph nodes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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?
Measured: 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 procedure will be documented on video and will be reviewed by the investigational team for accuracy of tracer injections and learning purposes.
Measured: 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)?
Measured: The data of each patient will be assesses within 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start9 Mar 2020
- Primary completion11 Jan 2022
- Study completion11 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hans Kaanders, MD, PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04068636
- Sponsor's protocol ID
- FLEX-NODE
- Acronym
- FLEX-NODE
- Status last verified
- Apr 2022
- First submitted
- 8 Aug 2019
- Last updated
- 29 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sentinel Node Localization in Larynx and Pharynx Cancers After Flexible Endoscopy-guided Tracer Injection: a Feasibility Study.
- ClinicalTrials.gov ID
- NCT04068636
- Acronym / sponsor ID
- FLEX-NODE / FLEX-NODE
- Conditions
- Head and Neck Cancer, Lymph Node Metastases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 9 Mar 2020 (actual)
- Primary completion
- 11 Jan 2022 (actual)
- Study completion
- 11 Jan 2022 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study explores the feasibility of sentinel lymph node identification in pharynx and larynx cancers using flexible endoscopy-guided tracer injection.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Flexible endoscopy guided SNB in larynx and pharynx cancers. | Experimental | Procedure: Radioactive tracer injection via flexible endoscopy and SPECT scan for visualization of lymph nodes.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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Flexible endoscopy guided SNB in larynx and pharynx cancers. |
Primary outcome
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?
2 secondary outcomes
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans Kaanders, MD, PhD principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radioactive tracer injection via flexible endoscopy and SPECT scan for visualization of lymph nodes. in people with Head and Neck Cancer and Lymph Node Metastases, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2022.