Mouth cancer occult lymph node metastasis
Conditions
Interventions
None listed
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The sensitivity and negative predictive value of CT lymphography as compared with conventional lymphoscintigraphy for SLNB. In addition, the sensitivity and negative predictive value for preoperative CT lymphography combined with conventional preoperative lymphoscintigraphy. | — |
Secondary
| Measure | Time frame |
|---|---|
| • To compare the number of CT lymphographic detected SLNs with those detected by means of 99mTc-nanocolloid lymphoscintigraphy on a per-subject basis. • To compare the number of CT lymphographic detected higher-echelon nodes with those detected by means of 99mTc-nanocolloid lymphoscintigraphy on a per-subject basis. • To compare histopathologic assessment (presence or absence of metastasis) of the excised lymph node(s) detected by conventional preoperative 99mTc-nanocolloid lymphoscintigraphy and intraoperative gammaprobe localization, with the SLNs identified by means of preoperative CT lymphography. • Observing contralateral drainage patterns in lateralized tumors and compare these patterns between CT lymphography and conventional 99mTc-nanocolloid lymphoscintigraphy. • To assess pairwise inter-observer agreements between CT lymphography and conventional 99mTc-nanocolloid lymphoscintigraphy regarding preoperative SLN detection. | — |
Countries
Netherlands
Outcome results
None listed