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

Study Overview
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Brief Summary
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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

Official Title
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Mapping of Sentinel Lymph Node Drainage Using SPECT to Tailor Highly-Selective Elective Nodal Irradiation in Node-Negative Neck of Patients With Head and Neck Cancer (SUSPECT)

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Radiation: radiation in Squamous Head and Neck Cancer


Participation Criteria
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Eligibility Criteria
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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: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Squamous Head and Neck Cancer<br>radiation | Radiation: radiation in Squamous Head and Neck Cancer<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiotherapy, Sentinel Node Mapping, Spect