GALLIUM (68GA) CHLORIDE for Parotid gland carcinoma

Inclusion criteria

• {"criterion_text":"- 1.The patient has provided written informed consent authorization before participating in the study."}
• {"criterion_text":"- 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)."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 4. The patient is a candidate for parotidectomy and elective (selective or modified radical) neck dissection."}
• {"criterion_text":"- 5. The patient is ≥18 years of age at the time of consent."}
• {"criterion_text":"- 6. The patient has an ECOG status of Grade 0 – 2 (see Appendix 4: ECOG Performance Status Grading)"}

Exclusion criteria

• {"criterion_text":"- 1. The patient is incapacitated."}
• {"criterion_text":"- 2. The patient has had a previous allergic reaction after administration of a radionuclide tracer."}
• {"criterion_text":"- 3. The patient has clinical or radiological evidence of metastatic cancer to the regional lymph nodes."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 5. The patient is actively receiving systemic cytotoxic chemotherapy."}
• {"criterion_text":"- 6.The patient is on immunosuppressive, anti-monocyte, or immunomodulatory therapy."}

Primary endpoints

• {"endpoint_text":"- Primary endpoint is the feasibility of the sentinel lymph node biopsy (SLNB) procedure in patients with carcinoma of the parotid gland with a clinically negative neck scheduled for parotidectomy with elective neck dissection. Detection of SLNs, using 68Ga-tilmanocept PET/CT lymphoscintigraphy, is considered feasible, if 68Ga-tilmanocept PET/CT lymphoscintigraphy is able to depict SLNs in at least 8 out of 10 patients and excise the SLNs peroperatively.","definition_or_measurement_approach":"Feasibility defined as 68Ga-tilmanocept PET/CT lymphoscintigraphy depicting sentinel lymph nodes in at least 8 out of 10 patients and successful peroperative excision of the SLNs."}

Secondary endpoints

• {"endpoint_text":"- To compare histopathologic results (presence or absence of isolated tumour cells and (micro-)metastasis) of the excised sentinel lymph node(s), and elective neck dissection specimens. To investigate in which levels the sentinel lymph nodes are localized and the number of sentinel lymph nodes. To investigate the best timing of PET/CT. The incidence and degree of postoperative complications, graded by means of the Clavien-Dindo classification of Surgical Complications","definition_or_measurement_approach":"Compare histopathology of excised SLNs vs elective neck dissection specimens (presence/absence of isolated tumour cells and (micro-)metastasis); record anatomical levels and number of SLNs; evaluate timing of PET/CT; record incidence and grade of postoperative complications using the Clavien-Dindo classification."}

Netherlands

Earliest CTIS Part Ii Submission Date

17-06-2024

Latest Decision Or Authorization Date

12-07-2024

Processing Time Days

25

Number Of Sites

1

Number Of Participants

10

Primary sponsor

Full Name

Universitair Medisch Centrum Utrecht

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands