Squamous Cell Carcinoma of the Nasal VestibuleNCT05637307
Sentinel NOSE Study: Prospective Registration Study on the Sentinel Node Procedure for Bulky Squamous Cell Carcinoma of the Nasal Vestibule.
A study testing Sentinel node procedure in people with Squamous Cell Carcinoma of the Nasal Vestibule, run by Radboud University Medical Center at 2 sites in Netherlands.
Trial summary
Management of the neck in Wang cT1-T2N0 nasal vestibule carcinoma (NVC) has been an ongoing point of discussion. As the disease is rare publications are scarce and published regional recurrence rates vary widely between 0% up to 23%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of the Nasal Vestibule
- What is being tested?
- Sentinel node procedure
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesNetherlands
- Study dates
- 15 Nov 2020to 16 Jan 2024
- 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
- Aged 18 years or older.
- WHO performance score of 0, 1 or 2.
- Newly diagnosed T1 or T2 squamous cell carcinoma of the nasal vestibule.
- Tumor diameter ≥1.5 cm and/or tumor volume ≥1.5cm3
- Clinically negative neck (N0).
- Patients planned to undergo curative treatment.
- Patient provided written informed consent
Who cannot join
- Prior allergic reaction to either indocyanide green, 99m-Technetium nanocolloid or human colloidal albumin.
- Pregnancy.
- Previous surgery or radiotherapy of the neck.
- Concurrent secondary head-and-neck tumor.
- Unable to provide informed consent
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Anthoni van Leeuwenhoekhuis
Amsterdam, 1086 CX
Radboud UMC
Nijmegen, 6500 HB
About this study
Official title: Sentinel NOSE Study: Prospective Registration Study on the Sentinel Node Procedure for Bulky Squamous Cell Carcinoma of the Nasal Vestibule
Management of the neck in Wang cT1-T2N0 nasal vestibule carcinoma (NVC) has been an ongoing point of discussion. As the disease is rare publications are scarce and published regional recurrence rates vary widely between 0% up to 23%. In general, literature recommends adequate radiological neck staging followed by a watchful waiting policy, as overall regional recurrence rates are low (5-10%).
However, according to recent findings, a subset of patients with large or voluminous cT1-T2N0 NVC is deemed at high risk of nodal involvement (20-40% regional recurrence) but receive no elective treatment, although it is well known that presence of nodal metastases impacts the prognosis of head and neck cancer (HNC) dramatically. Whereas elective neck dissection may be too aggressive, sentinel node biopsy (SNB) has been proven a reliable and safe alternative to bridge the gap between imaging and neck dissection.
Read more
SNB is currently routinely employed in most HNC centres in the Netherlands and is considered state of the art care, but its application in HNC is limited to oral cavity carcinoma and squamous cell carcinoma of the skin. Following the observation of increased risk of (occult) nodal metastases and regional recurrence in bulky tumors, the sentinel node procedure seems ideally suited for cT1-T2N0 NVC patients. Its superficial tumor localization is easily accessible for peritumoral Tc-99m-nanocolloid-ICG tracer injection. The purpose of this prospective registration study is to document the clinical introduction of the sentinel node procedure for bulky nasal vestibule carcinoma in our centre by protocol, and to identify and address possible unexpected difficulties specific for this tumor site. Ultimately, the goal will be routine and wide implementation of SNB in the NVC subgroup known to be at risk of nodal involvement, as a means to improve regional disease staging and control.
Objective: To prospectively document the introduction of the sentinel node procedure for bulky cT1-T2N0 nasal vestibule carcinoma in patients at risk of nodal involvement.
Study design: Single centre prospective registration study. To be extended with a second centre.
Study population: Patients with Wang cT1-T2N0 squamous cell carcinoma of the nasal vestibule, with tumor diameter ≥1.5 cm and/or tumor volume ≥1.5 cm3, with a WHO performance score of 2 or lower and no history of previous surgery or radiotherapy of the neck.
Interventions: 1. Subcutaneous peritumoral radioactive tracer injection followed by lymphoscintigraphy and Single Photon Emission Computed Tomography (SPECT) imaging for sentinel lymph node visualization.
- Surgical sentinel node biopsy and histopathological examination of harvested nodes following the abovementioned imaging.
Main study parameters/endpoints: The primary endpoint of this study will be successful identification of sentinel nodes on lymphoscintigraphy and SPECT imaging. The procedure will be considered feasible when one or more sentinel nodes can be identified and localized in at least 7 out of the 10 patients..
Read the detailed description
Management of the neck in Wang cT1-T2N0 nasal vestibule carcinoma (NVC) has been an ongoing point of discussion. As the disease is rare publications are scarce and published regional recurrence rates vary widely between 0% up to 23%. In general, literature recommends adequate radiological neck staging followed by a watchful waiting policy, as overall regional recurrence rates are low (5-10%).
However, according to recent findings, a subset of patients with large or voluminous cT1-T2N0 NVC is deemed at high risk of nodal involvement (20-40% regional recurrence) but receive no elective treatment, although it is well known that presence of nodal metastases impacts the prognosis of head and neck cancer (HNC) dramatically. Whereas elective neck dissection may be too aggressive, sentinel node biopsy (SNB) has been proven a reliable and safe alternative to bridge the gap between imaging and neck dissection.
SNB is currently routinely employed in most HNC centres in the Netherlands and is considered state of the art care, but its application in HNC is limited to oral cavity carcinoma and squamous cell carcinoma of the skin. Following the observation of increased risk of (occult) nodal metastases and regional recurrence in bulky tumors, the sentinel node procedure seems ideally suited for cT1-T2N0 NVC patients. Its superficial tumor localization is easily accessible for peritumoral Tc-99m-nanocolloid-ICG tracer injection. The purpose of this prospective registration study is to document the clinical introduction of the sentinel node procedure for bulky nasal vestibule carcinoma in our centre by protocol, and to identify and address possible unexpected difficulties specific for this tumor site. Ultimately, the goal will be routine and wide implementation of SNB in the NVC subgroup known to be at risk of nodal involvement, as a means to improve regional disease staging and control.
Objective: To prospectively document the introduction of the sentinel node procedure for bulky cT1-T2N0 nasal vestibule carcinoma in patients at risk of nodal involvement.
Study design: Single centre prospective registration study. To be extended with a second centre.
Study population: Patients with Wang cT1-T2N0 squamous cell carcinoma of the nasal vestibule, with tumor diameter ≥1.5 cm and/or tumor volume ≥1.5 cm3, with a WHO performance score of 2 or lower and no history of previous surgery or radiotherapy of the neck.
Interventions: 1. Subcutaneous peritumoral radioactive tracer injection followed by lymphoscintigraphy and Single Photon Emission Computed Tomography (SPECT) imaging for sentinel lymph node visualization.
- Surgical sentinel node biopsy and histopathological examination of harvested nodes following the abovementioned imaging.
Main study parameters/endpoints: The primary endpoint of this study will be successful identification of sentinel nodes on lymphoscintigraphy and SPECT imaging. The procedure will be considered feasible when one or more sentinel nodes can be identified and localized in at least 7 out of the 10 patients..
The secondary outcomes will be: yield of at least one lymph node after biopsy, incidence of surgical complications and pain score during and after peritumoral tracer injection and tracer.
- Being tested
- Sentinel node procedure
- Keywords
- nasal vestibule, sentinel node, nodal metastases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sentinel node procedureProcedure or surgery
Injection of radio-active tracer in the tumor before brachytherapy treatment, visualization of sentinel nodes by SPECT, and extirpation of sentinel nodes by surgery
| Study group | Role | What they receive |
|---|---|---|
| sentinel node procedure | Experimental | Participants will indergo the standard treatment for their disease ( i.e. brachytherapy) but a sentinel node procedure will be added to their treatment Receives: Procedure: Sentinel node procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of identification of sentinel nodes
the number of identified nodes on SPECT that can actually be retrieved at subsequent surgery
Measured: 1 week
Secondary outcomes (3)
pain scores
Pain scores during and immediately after the injection of nanocolloid on a visual anlog scale ranging from 0-10
Measured: 2 hours after injection
analgetics
use of analgetics ( both orally and locally administered)
Measured: 2 hours after injection
surgical complications
complications after surgery as registered in our hospital record database
Measured: 30 days after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start15 Nov 2020
- Primary completion15 Jan 2024
- Study completion16 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma of the Nasal VestibuleStudies 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hans Kaanders, Prof., PhD, MD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05637307
- Sponsor's protocol ID
- Sentinel NOSE
- Status last verified
- Dec 2024
- First submitted
- 19 Nov 2020
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data wil be available upon request
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sentinel NOSE Study: Prospective Registration Study on the Sentinel Node Procedure for Bulky Squamous Cell Carcinoma of the Nasal Vestibule
- ClinicalTrials.gov ID
- NCT05637307
- Acronym / sponsor ID
- Sentinel NOSE
- Keywords
- nasal vestibule, sentinel node, nodal metastases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 15 Nov 2020 (actual)
- Primary completion
- 15 Jan 2024 (actual)
- Study completion
- 16 Jan 2024 (actual)
- First posted
- 5 Dec 2022 (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.
Management of the neck in Wang cT1-T2N0 nasal vestibule carcinoma (NVC) has been an ongoing point of discussion. As the disease is rare publications are scarce and published regional recurrence rates vary widely between 0% up to 23%. In general, literature recommends adequate radiological neck staging followed by a watchful waiting policy, as overall regional recurrence rates are low (5-10%).
However, according to recent findings, a subset of patients with large or voluminous cT1-T2N0 NVC is deemed at high risk of nodal involvement (20-40% regional recurrence) but receive no elective treatment, although it is well known that presence of nodal metastases impacts the prognosis of head and neck cancer (HNC) dramatically. Whereas elective neck dissection may be too aggressive, sentinel node biopsy (SNB) has been proven a reliable and safe alternative to bridge the gap between imaging and neck dissection.
SNB is currently routinely employed in most HNC centres in the Netherlands and is considered state of the art care, but its application in HNC is limited to oral cavity carcinoma and squamous cell carcinoma of the skin. Following the observation of increased risk of (occult) nodal metastases and regional recurrence in bulky tumors, the sentinel node procedure seems ideally suited for cT1-T2N0 NVC patients. Its superficial tumor localization is easily accessible for peritumoral Tc-99m-nanocolloid-ICG tracer injection. The purpose of this prospective registration study is to document the clinical introduction of the sentinel node procedure for bulky nasal vestibule carcinoma in our centre by protocol, and to identify and address possible unexpected difficulties specific for this tumor site. Ultimately, the goal will be routine and wide implementation of SNB in the NVC subgroup known to be at risk of nodal involvement, as a means to improve regional disease staging and control.
Objective: To prospectively document the introduction of the sentinel node procedure for bulky cT1-T2N0 nasal vestibule carcinoma in patients at risk of nodal involvement.
Study design: Single centre prospective registration study. To be extended with a second centre.
Study population: Patients with Wang cT1-T2N0 squamous cell carcinoma of the nasal vestibule, with tumor diameter ≥1.5 cm and/or tumor volume ≥1.5 cm3, with a WHO performance score of 2 or lower and no history of previous surgery or radiotherapy of the neck.
Interventions: 1. Subcutaneous peritumoral radioactive tracer injection followed by lymphoscintigraphy and Single Photon Emission Computed Tomography (SPECT) imaging for sentinel lymph node visualization.
- Surgical sentinel node biopsy and histopathological examination of harvested nodes following the abovementioned imaging.
Main study parameters/endpoints: The primary endpoint of this study will be successful identification of sentinel nodes on lymphoscintigraphy and SPECT imaging. The procedure will be considered feasible when one or more sentinel nodes can be identified and localized in at least 7 out of the 10 patients..
Detailed description
Management of the neck in Wang cT1-T2N0 nasal vestibule carcinoma (NVC) has been an ongoing point of discussion. As the disease is rare publications are scarce and published regional recurrence rates vary widely between 0% up to 23%. In general, literature recommends adequate radiological neck staging followed by a watchful waiting policy, as overall regional recurrence rates are low (5-10%).
However, according to recent findings, a subset of patients with large or voluminous cT1-T2N0 NVC is deemed at high risk of nodal involvement (20-40% regional recurrence) but receive no elective treatment, although it is well known that presence of nodal metastases impacts the prognosis of head and neck cancer (HNC) dramatically. Whereas elective neck dissection may be too aggressive, sentinel node biopsy (SNB) has been proven a reliable and safe alternative to bridge the gap between imaging and neck dissection.
SNB is currently routinely employed in most HNC centres in the Netherlands and is considered state of the art care, but its application in HNC is limited to oral cavity carcinoma and squamous cell carcinoma of the skin. Following the observation of increased risk of (occult) nodal metastases and regional recurrence in bulky tumors, the sentinel node procedure seems ideally suited for cT1-T2N0 NVC patients. Its superficial tumor localization is easily accessible for peritumoral Tc-99m-nanocolloid-ICG tracer injection. The purpose of this prospective registration study is to document the clinical introduction of the sentinel node procedure for bulky nasal vestibule carcinoma in our centre by protocol, and to identify and address possible unexpected difficulties specific for this tumor site. Ultimately, the goal will be routine and wide implementation of SNB in the NVC subgroup known to be at risk of nodal involvement, as a means to improve regional disease staging and control.
Objective: To prospectively document the introduction of the sentinel node procedure for bulky cT1-T2N0 nasal vestibule carcinoma in patients at risk of nodal involvement.
Study design: Single centre prospective registration study. To be extended with a second centre.
Study population: Patients with Wang cT1-T2N0 squamous cell carcinoma of the nasal vestibule, with tumor diameter ≥1.5 cm and/or tumor volume ≥1.5 cm3, with a WHO performance score of 2 or lower and no history of previous surgery or radiotherapy of the neck.
Interventions: 1. Subcutaneous peritumoral radioactive tracer injection followed by lymphoscintigraphy and Single Photon Emission Computed Tomography (SPECT) imaging for sentinel lymph node visualization.
- Surgical sentinel node biopsy and histopathological examination of harvested nodes following the abovementioned imaging.
Main study parameters/endpoints: The primary endpoint of this study will be successful identification of sentinel nodes on lymphoscintigraphy and SPECT imaging. The procedure will be considered feasible when one or more sentinel nodes can be identified and localized in at least 7 out of the 10 patients..
The secondary outcomes will be: yield of at least one lymph node after biopsy, incidence of surgical complications and pain score during and after peritumoral tracer injection and tracer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sentinel node procedure | Experimental | Procedure: Sentinel node procedureParticipants will indergo the standard treatment for their disease ( i.e. brachytherapy) but a sentinel node procedure will be added to their treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged 18 years or older.
- WHO performance score of 0, 1 or 2.
- Newly diagnosed T1 or T2 squamous cell carcinoma of the nasal vestibule.
- Tumor diameter ≥1.5 cm and/or tumor volume ≥1.5cm3
- Clinically negative neck (N0).
Key exclusion criteria (5 listed)
- Prior allergic reaction to either indocyanide green, 99m-Technetium nanocolloid or human colloidal albumin.
- Pregnancy.
- Previous surgery or radiotherapy of the neck.
- Concurrent secondary head-and-neck tumor.
- 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 |
|---|---|---|
| Sentinel node procedureInjection of radio-active tracer in the tumor before brachytherapy treatment, visualization of sentinel nodes by SPECT, and extirpation of sentinel nodes by surgery | Procedure or surgery | sentinel node procedure |
Primary outcome
Feasibility of identification of sentinel nodes
Time frame: 1 week
the number of identified nodes on SPECT that can actually be retrieved at subsequent surgery
3 secondary outcomes
pain scores
Time frame: 2 hours after injection
analgetics
Time frame: 2 hours after injection
surgical complications
Time frame: 30 days after the procedure
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 17 Dec 2024.
- Individual participant dataSharing planned: Yes. Data wil be available upon request
Related trials for Squamous Cell Carcinoma of the Nasal Vestibule
Not yet recruitingObservational study
Brachytherapy (Interventional Radiotherapy) for Squamous Cell Carcinomas of the Nasal Vestibule: Optimization of Dose and Technique
Carcinoma Nasal Vestibule
RecruitingObservational study
Survival and Prognostic Factors of Squamous Cell Carcinoma of the Nasal Vestibule
Nasal Vestibule Carcinoma, Rhinectomy
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, Prof., PhD, MD principal investigator
Radboud University Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sentinel node procedure in people with Squamous Cell Carcinoma of the Nasal Vestibule, run by Radboud University Medical Center at 2 sites 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 7 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 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Feasibility of identification of sentinel nodes (time frame: 1 week). 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 17 Dec 2024.