Sentinel lymph node detection in early oral cancer using Gallium-68-Tilmanocept PET-CT

niversity Medical Center Utrecht0 个研究点目标入组 94 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

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•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 tumor dimen-sions of >2 cm and =4 cm with DOI >10 mm), N0, M0 (see Appendix 6: TNM Staging).
•3. Clinical nodal staging (N0) has been confirmed by negative results from ultrasound guid-ed fine needle aspiration cytology within 30 days of the SLN procedure.
•4. The patient is a candidate for transoral excision.
•5. Patients with prior malignancy of the head and neck area are allowed, provided the pa-tient 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.
•6. The patient is =18 years of age at the time of consent.
•7. The patient has an ECOG status of Grade 0 – 2 (see Appendix 7: Performance Status Criteria).

•1. The patient has a diagnosis of squamous cell carcinoma of the head and neck in the fol-lowing anatomical areas: non-mobile base of the tongue, oropharynx, nasopharynx, hy-popharynx, and larynx.
•2. The patient is incapacitated.
•3. The patient has had a previous allergic reaction after administration of a radionuclide tracer.
•4. The patient has had other nuclear imaging studies, conducted within 10 days (240 hours) of injection.
•5. The patient has clinical or radiological evidence of metastatic cancer to the regional lymph nodes.
•6. The patient has a history of neck dissection, or gross injury to the neck that would pre-clude reasonable surgical dissection for this trial, or radiotherapy to the neck.
•7. The patient is actively receiving systemic cytotoxic chemotherapy.
•8. The patient is on immunosuppressive, anti-monocyte, or immunomodulatory therapy.

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