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CompletedNCT02572661SUSPECTUpdated Jun 27, 2019

Mapping of Sentinel Lymph Node Drainage Using SPECT (SUSPECT) (SUSPECT)

An interventional study of radiation in Squamous Head and Neck Cancer in Head and Neck Cancer, sponsored by The Netherlands Cancer Institute. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-06-27.

Sponsored by The Netherlands Cancer Institute · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
61
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This study aims to explore the feasibility, safety and outcome of a non-invasive sentinel node mapping (SNM) to individually tailor the elective nodal irradiation (ENI) to the ipsilateral neck only and to exclude the contralateral negative neck from the irradiation fields when there is no draining sentinel node. Subsequently the dose to the salivary glands, mucosal area and the swallowing and chewing muscles and structures involved in voicing and articulation will significantly be reduced

02

Conditions studied

  • Head and Neck Cancer

Keywords

  • Radiotherapy, Sentinel Node Mapping, Spect
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In context

Head and Neck Neoplasms

2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.

This study's enrollment of 61 is above the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.

Browse Head and Neck Neoplasms studies →

Lead sponsor

The Netherlands Cancer Institute is the lead sponsor of 224 studies on the registry; 66 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Newly diagnosed patients with histopathologic proven primary HNSCC (T1 -3 N0 -1) located in the oral cavity, oropharynx, larynx (except T1 glottic ), and hypopharynx, not crossing the midline and planned for treatment with (chemo)radiotherapy in curative setting
  • No chemotherapy or surgery prior to inclusion
  • No distant metastatic spread at the time of inclusion
  • Age ≥ 18 years
  • WHO performance status 0 or 1
  • Signed written informed consent

Exclusion criteria

Exclusion Criteria:

  • Patients with previously radiation treatment in the head and neck region, for any reason
  • Patients with previous neck dissection
  • Patients with recurrent or second primary tumor in the head and neck region
  • Patients with head and neck malignancies arising from skin, lip, nose, sinuses, nasopharynx, salivary glands, thyroid gland or esophagus
  • Previous history of cancer in the last five years (excluding basal cell carcinoma of the skin and in situ SCC of the cervix)
  • 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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
61 participants (actual)

Study arms

  • Other
    Squamous Head and Neck Cancer

    radiation

    Radiation: radiation in Squamous Head and Neck Cancer

Interventions

  • Radiationradiation in Squamous Head and Neck Cancer
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What researchers measure

Primary outcomes

  1. Feasibility and safety of single side radiation therapy measured by physical examination and toxicity measurement by CTCAE 4.03 at 12 weeks

    mapping of sentinel lymph node drainage to indentify groups at low risk of the probability of contra regionale failure is to be estimated to be 2% at 2 years. A recurrrence rate of \>15% will be assumed unacceptable

    Time frame: 12 weeks

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Study locations

1 site
  • the Netherlands Cancer Instiute
    Amsterdam, 1066 CX, Netherlands
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 27, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02572661
Lead sponsor
The Netherlands Cancer Institute
Responsible party
Sponsor
First posted
Oct 9, 2015
Start date
Jul 23, 2015
Primary completion
Nov 9, 2018
Completion
Nov 9, 2018
Last update
Jun 27, 2019

Study contacts

Abrahim Al-Mamgani, MD, PhD
principal investigator · The Netherlands Cancer Institute

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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