Identification of lymphatic metastasis in patients with parotid gland carcinoma by means of sentinel lymph node biopsy using 68-galium-tilmanocept PET-CT.

Phase 1

• Conditions: The IMP will be used for the identification of sentinel lymph node(s) in patients with parotid gland carcinoma.; MedDRA version: 21.1Level: LLTClassification code 10026329Term: Malignant neoplasm of parotid glandSystem Organ Class: 100000004864; MedDRA version: 20.0Level: LLTClassification code 10072873Term: Sentinel lymph node mappingSystem Organ Class: 100000004848; MedDRA version: 20.1Level: LLTClassification code 10073554Term: Sentinel node biopsySystem Organ Class: 100000004848; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

• Registration Number: EUCTR2021-003068-28-NL
• Lead Sponsor: niversity Medical Center Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-23
• Last Update Posted: 18 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified