Head and Neck CancerSUSPECT-2NCT03968679
Lymph Drainage Mapping for Tailoring Elective Nodal Irradiation in Head and Neck Cancer
A study testing Unilateral elective nodal irradiation in people with Head and Neck Cancer, run by The Netherlands Cancer Institute at 1 site in Netherlands.
Trial summary
This study aims to explore the safety and outcome of lymph drainage mapping(LDM) to individually tailor the elective nodal irradiation (ENI) to the ipsilateral neck only. The goal is to exclude the contralateral negative neck from the irradiation fields when there is no contralateral draining sentinel node. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Unilateral elective nodal irradiation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteNetherlands
- Study dates
- 22 Jul 2019to 1 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Newly diagnosed and histopathologically proven primary HNSCC
- T1-4N0-2b
- Tumor does not cross midline
- WHO performance status 0 or 1
- Signed written informed consent
Who cannot join
- Distant metastatic spread at the time of inclusion
- Chemotherapy or surgery (for the present tumor), prior to inclusion
- Previous radiation treatment in the head and neck region, for any reason
- Previous neck dissection
- Recurrent or second primary tumor in the head and neck region
- Head and neck malignancies arising from skin, lip, nose, sinuses, nasopharynx, salivary glands, thyroid gland or esophagus
Show all 9Show fewer
- Pregnancy or no active contraception for pre-menopausal women
- Known hypersensitivity to iodine or nanocolloid injection
- Having any condition (physical, mental, sociological) that interferes with the informed consent procedure and follow-up schedules
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mapping of Sentinel Lymph Node Drainage Using SPECT/CT to Tailor Highly Selective Elective Nodal Irradiation in Node-negative Neck of Patients With Head and Neck Cancer
This study aims to explore the safety and outcome of lymph drainage mapping(LDM) to individually tailor the elective nodal irradiation (ENI) to the ipsilateral neck only. The goal is to exclude the contralateral negative neck from the irradiation fields when there is no contralateral draining sentinel node. In case contralateral lymph drainage is found on SPECT/CT, a contralateral sentinel node procedure (SNP) is performed to remove the draining node. The patient will only receive contralateral ENI if (micro/macro)metastasis are found in this contralateral sentinel node.
Read the detailed description
The SUSPECT2 study is a modified concept from the first SUSPECT study (N14SUS). The first study investigated whether lymph drainage mapping (LDM) using SPECT/CT was a safe and feasible method to exclude the contralateral neck from irradiation, or, in case of contralateral lymph drainage, to tailor the contralateral ENI field to the level containing the tracer accumulation. In this study, large dose reductions to most organs at risk were realized, as well as significant reductions of both short term (mucositis, dysphagia) and long term (xerostomia, dysphagia) toxicities.
Firstly, the SUSPECT2 study aims to expand the inclusion criteria of the original SUSPECT study. Secondly, it aims to further reduce the proportion of patients that undergoes bilateral ENI, by performing a contralateral sentinel node procedure (SNP) in case of contralateral lymph drainage. The patient will only receive contralateral ENI if (micro/macro)metastasis are found in this contralateral sentinel node.
- Conditions
- Head and Neck Cancer
- Being tested
- Unilateral elective nodal irradiation
- Keywords
- head and neck cancer, lymph drainage mapping, sentinel node procedure, radiotherapy, unilateral elective neck irradiation
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unilateral elective nodal irradiationRadiation
After injection of nanocolloid tracer submucosally around the tumor, patients undergo lymph drainage mapping (LDM) using SPECT/CT. If no contralateral drainage is visualized, the patient receives unilateral elective nodal irradiation (ENI). In case of contralateral lymph drainage, a contralateral sentinel node procedure is performed. If pathologic evaluation finds no metastasis, the patient receives unilateral ENI. If (micro/macro) metastasis are found, the patient will receive bilateral ENI.
| Study group | Role | What they receive |
|---|---|---|
| Unilateral elective nodal irradiation | Experimental | Exclusion of contralateral neck from elective nodal irradiation, based on results of SPECT/CT and (in case of contralateral drainage) contralateral sentinel node procedure. Receives: Radiation: Unilateral elective nodal irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contralateral regional failure
Cumulative incidence of contralateral regional metastasis.
Measured: 1 year
Secondary outcomes (2)
Treatment toxicity
Physician-rated early and late treatment toxicity (CTCAE v5.0)
Measured: Until 2 years after end of radiotherapy
Health-related quality of life
Health-related quality of life after treatment (EORTC QLQ-C30/HN35)
Measured: Until 18 months after end of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start22 Jul 2019
- Primary completion14 Jan 2026
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by The Netherlands Cancer InstituteThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Radboud University Medical Center
- Responsible party
- Sponsor
- Investigators
- Abrahim Al-Mamgani, MD, PhD, Principal investigator, The Netherlands Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03968679
- Sponsor's protocol ID
- M19SUS
- Acronym
- SUSPECT-2
- Status last verified
- Feb 2026
- First submitted
- 27 May 2019
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
de Veij Mestdagh PD, Schreuder WH, Vogel WV, Donswijk ML, van Werkhoven E, van der Wal JE, Dirven R, Karakullukcu B, Sonke JJ, van den Brekel MWM, Marijnen CAM, Al-Mamgani A. Mapping of sentinel lymph node drainage using SPECT/CT to tailor elective nodal irradiation in head and neck cancer patients (SUSPECT-2): a single-center prospective trial. BMC Cancer. 2019 Nov 14;19(1):1110. doi: 10.1186/s12885-019-6331-8.
PubMed 31727019
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mapping of Sentinel Lymph Node Drainage Using SPECT/CT to Tailor Highly Selective Elective Nodal Irradiation in Node-negative Neck of Patients With Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT03968679
- Acronym / sponsor ID
- SUSPECT-2 / M19SUS
- Conditions
- Head and Neck Cancer
- Keywords
- head and neck cancer, lymph drainage mapping, sentinel node procedure, radiotherapy, unilateral elective neck irradiation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Collaborators
- Radboud University Medical Center
- Study start
- 22 Jul 2019 (actual)
- Primary completion
- 14 Jan 2026 (actual)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 30 May 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 aims to explore the safety and outcome of lymph drainage mapping(LDM) to individually tailor the elective nodal irradiation (ENI) to the ipsilateral neck only. The goal is to exclude the contralateral negative neck from the irradiation fields when there is no contralateral draining sentinel node. In case contralateral lymph drainage is found on SPECT/CT, a contralateral sentinel node procedure (SNP) is performed to remove the draining node. The patient will only receive contralateral ENI if (micro/macro)metastasis are found in this contralateral sentinel node.
Detailed description
The SUSPECT2 study is a modified concept from the first SUSPECT study (N14SUS). The first study investigated whether lymph drainage mapping (LDM) using SPECT/CT was a safe and feasible method to exclude the contralateral neck from irradiation, or, in case of contralateral lymph drainage, to tailor the contralateral ENI field to the level containing the tracer accumulation. In this study, large dose reductions to most organs at risk were realized, as well as significant reductions of both short term (mucositis, dysphagia) and long term (xerostomia, dysphagia) toxicities.
Firstly, the SUSPECT2 study aims to expand the inclusion criteria of the original SUSPECT study. Secondly, it aims to further reduce the proportion of patients that undergoes bilateral ENI, by performing a contralateral sentinel node procedure (SNP) in case of contralateral lymph drainage. The patient will only receive contralateral ENI if (micro/macro)metastasis are found in this contralateral sentinel node.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Unilateral elective nodal irradiation | Experimental | Radiation: Unilateral elective nodal irradiationExclusion of contralateral neck from elective nodal irradiation, based on results of SPECT/CT and (in case of contralateral drainage) contralateral sentinel node procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Newly diagnosed and histopathologically proven primary HNSCC
- T1-4N0-2b
- Tumor does not cross midline
- WHO performance status 0 or 1
- Signed written informed consent
Key exclusion criteria (9 listed)
- Distant metastatic spread at the time of inclusion
- Chemotherapy or surgery (for the present tumor), prior to inclusion
- Previous radiation treatment in the head and neck region, for any reason
- Previous neck dissection
- Recurrent or second primary tumor in the head and neck region
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 |
|---|---|---|
| Unilateral elective nodal irradiationAfter injection of nanocolloid tracer submucosally around the tumor, patients undergo lymph drainage mapping (LDM) using SPECT/CT. If no contralateral drainage is visualized, the patient receives unilateral elective nodal irradiation (ENI). In case of contralateral lymph drainage, a contralateral sentinel node procedure is performed. If pathologic evaluation finds no metastasis, the patient receives unilateral ENI. If (micro/macro) metastasis are found, the patient will receive bilateral ENI. | Radiation | Unilateral elective nodal irradiation |
Primary outcome
Contralateral regional failure
Time frame: 1 year
Cumulative incidence of contralateral regional metastasis.
2 secondary outcomes
Treatment toxicity
Time frame: Until 2 years after end of radiotherapy
Health-related quality of life
Time frame: Until 18 months after end of radiotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Derived from this study: PubMed 31727019de Veij Mestdagh PD, Schreuder WH, Vogel WV, Donswijk ML, van Werkhoven E, van der Wal JE, Dirven R, Karakullukcu B, Sonke JJ, van den Brekel MWM, Marijnen CAM, Al-Mamgani A. Mapping of sentinel lymph node drainage using SPECT/CT to tailor elective nodal irradiation in head and neck cancer patients (SUSPECT-2): a single-center prospective trial. BMC Cancer. 2019 Nov 14;19(1):1110. doi: 10.1186/s12885-019-6331-8.
- Individual participant dataSharing planned: No
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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.
Abrahim Al-Mamgani, MD, PhD principal investigator
The Netherlands Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unilateral elective nodal irradiation in people with Head and Neck Cancer, run by The Netherlands Cancer Institute 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 9 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: under way, not looking for participants, as of the sponsor's last update on 4 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Contralateral regional failure (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03968679, which also lists 1 linked publication.
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 4 Feb 2026.