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 - SUSPECT-2

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 - SUSPECT-2 - SUSPECT-2

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON54554

Enrollment

Registered

2019-05-23

Start date

2019-07-22

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer

Interventions

Injection of radioactive tracer submucosally around and in the tumor

subsequently lymph drainage mapping using SPECT/CT and contralateral sentinel node procedure (in case of contralateral lymph drainage). Unilateral or bilateral elective nodal irradiation based on re

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Newly diagnosed and histopathologically proven lateralized primary HNSCC, T1-4N0-2b without midline involvement, originating at one side of the oral cavity, oropharynx, larynx (except T1 glottic), and hypopharynx, and planned for treatment with primary radiotherapy, chemo-radiotherapy or immuno-radiotherapy in curative setting • Age >= 18 years • WHO performance status 0 or 1 • Signed written informed consent

Exclusion criteria

Exclusion criteria: • 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 • 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

Design outcomes

Primary

Measure	Time frame
Cumulative incidence of contralateral regional metastasis at 1 year after treatment	—

Secondary

Measure	Time frame
Toxicity Quality of Life Prevalence of metastatic disease in contralateral sentinel nodes removed based on lymph drainage mapping using SPECT/CT at baseline	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)