Sentinel lymph node biopsy in patients with parotid gland carcinoma using a combination of 99mTc-nanocolloid and 68Ga-tilmanocept PET/CT: A feasibility study. (SNparotis)
- Conditions
- Carcinoma of the parotid glandMedDRA version: 21.1Level: LLTClassification code: 10026329Term: Malignant neoplasm of parotid gland Class: 10029104Therapeutic area: Analytical,Diagnostic,Therapeutic Techniques and Equipment [E]-Surgical Procedures, Operative [E04]
- Registration Number
- CTIS2024-514233-37-00
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 10
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)
1. The patient is incapacitated. 2. The patient has had a previous allergic reaction after administration of a radionuclide tracer. 3. The patient has clinical or radiological evidence of metastatic cancer to the regional lymph nodes. 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method