Sentinel lymph node detection of cervical occult lymph node metastases in patients with parotid gland carcinoma by means of sentinel node biopsy using 68-galium-tilmanocept PET-CT. - SNParotid

niversity Medical Center Utrecht0 sites10 target enrollmentStarted: September 23, 2021Last updated: October 18, 2021

Conditions

Trial Snapshot

No summary available.

•1. The patient has provided written informed consent authorization before participating in the study.
•2. The patient has a diagnosis of primary carcinoma of the parotid gland, and is stage T1-T4, cN0, M0 (see Appendix 3: TNM staging AJCC UICC 8th edition).
•3. Clinical nodal staging (cN0) has been confirmed by negative results from CT, MRI, PET/CT and/or ultrasound-guided fine needle aspiration cytology within 30 days of the SLNB procedure.
•4. The patient is a candidate for parotidectomy and elective (selective or modified radical) neck dissection.
•5. The patient is =18 years of age at the time of consent.
•6. The patient has an ECOG status of Grade 0 – 2 (see Appendix 4: ECOG Performance Status Grading).
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 5
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 5

•1. The patient is incapacitated.
•2. The patient is pregnant.
•3. The patient has had a previous allergic reaction after administration of a radionuclide tracer.
•4. 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.
•5. The patient is actively receiving systemic cytotoxic chemotherapy.
•6. The patient is on immunosuppressive, anti-monocyte, or immunomodulatory therapy.

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