Sentinel lymph node (SLN) detection in oral cancer: a head to head comparison between 99mTc-Tilmanocept and 99mTc-Nanocoll - Lymphoseek (99mTc-Tilmanocept)

niversitair Medisch Centrum Utrecht0 个研究点目标入组 20 人开始时间: 待定最近更新: 2024年2月28日

试验速览

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•1. The patient has provided written informed consent authorization before participating in the trial.
•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, N0, M0 (see Appendix 3: TNM Staging).
•3. Clinical nodal staging (N0) has been confirmed by negative results from ultrasound guided 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 are allowed provided the patient meets both of the following criteria:
•* Underwent potentially curative therapy for all prior malignancies and is deemed low risk for recurrence; and
•* No malignancy for the past five years (except effectively treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix effectively treated with surgery alone or lobular carcinoma in situ of the breast treated with surgery alone), 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 4: Performance Status 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. The patient is pregnant or lactating.
•3. Patient is incapacitated
•4. The patient has clinical or radiological evidence of metastatic cancer to the regional lymph nodes.
•5. 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.
•6. The patient has had other nuclear imaging studies, including technetium 99m, conducted within 10 days (240 hours) of injection.
•7. The patient is actively receiving systemic cytotoxic chemotherapy.
•8. The patient is currently participating in another investigational drug trial or participated within 30 days prior to consenting.
•9. Patient is on immunosuppressive, anti-monocyte, or immunomodulatory therapy.

发起方

niversitair Medisch Centrum Utrecht