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.

Phase 3

Recruiting

Conditions: Parotid carcinoma
salivary gland tumor
10019190

Registration Number: NL-OMON51066

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

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).

Exclusion Criteria

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: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint of this study is the feasibility of the sentinel node<br /><br>biopsy procedure in patients with carcinoma of the parotid gland with N0 neck<br /><br>scheduled for parotidectomy with elective neck dissection, using preoperative<br /><br>68-galium-tilmanocept PET/CT combined with intraoperative gamma probe and<br /><br>fluorescence camera localization. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• To compare histopathologic results (presence or absence of isolated tumor<br /><br>cells and (micro-)metastasis) of the excised sentinel lymph node(s), and<br /><br>elective neck dissection specimens.<br /><br>• To investigate in which levels the sentinel lymph nodes are localized and the<br /><br>number of sentinel lymph nodes.<br /><br>• To investigate the best timing of PET/CT.<br /><br>• The incidence and degree of postoperative complications, graded by means of<br /><br>the Clavien-Dindo classification of Surgical Complications.</p><br>