Sentinel lymph node detection in early-stage oral cavity squamous cell carcinoma using computed tomographic lymphography

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 94

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
1. The patient has provided written informed consent authorization before
participating in the study.
2. The patient has a diagnosis of primary oral squamous cell carcinoma that is
anatomically located in: mucosal lip, buccal mucosa, lower alveolar ridge,
upper alveolar ridge, retromolar gingival (retromolar trigone),
floor-of-the-mouth, hard palate or oral (mobile) tongue, and is stage T1-T2 and
T3 (only when T3 is assessed based on tumour dimensions of >2 cm and <=4 cm with
DOI >10 mm), N0, M0.
3. Clinical nodal staging (N0) has been confirmed by negative results from
ultrasound guided fine needle aspiration cytology.
4. The patient is a candidate for transoral excision and sentinel lymph node
biopsy.
5. The patient has given informed consent for a surgical procedure regarding
his/her oncological treatment.
6. Patients with prior malignancy of the head and neck area are allowed,
provided the patient meets both of the following criteria:
• Underwent potentially curative therapy for all prior head and neck
malignancies and is deemed low risk for recurrence; and
• No head and neck malignancy for the past five years and no evidence of
recurrence.
7. The patient is >18 years of age at the time of consent.
8. The patient has an ECOG status of Grade 0 - 2.

Exclusion Criteria

1. The patient has a diagnosis of squamous cell carcinoma of the head and neck
in the following anatomical areas: non-mobile base of the tongue, oropharynx,
nasopharynx, hypopharynx, and larynx.
2. Patient is incapacitated.
3. Patient is pregnant or lactating.
4. Previous allergic reaction after administration of a CT-contrast-agent for
contrast enhanced CT-imaging.
5. Patient is known with manifest hyperthyroidism.
6. The patient has clinical or radiological evidence of metastatic cancer to
the regional lymph nodes.
7. The patient has a history of neck dissection, or gross injury to the neck
that would preclude reasonable surgical dissection for this trial, or
radiotherapy to the neck.
8. The patient is actively receiving systemic cytotoxic chemotherapy.
9. Patient is on immunosuppressive, anti-monocyte, or immunomodulatory
therapy.
10. Participation will result in unacceptable delay regarding oncological
treatment.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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