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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-003068-28-NL

Enrollment

Registered

2021-09-23

Start date

2021-09-29

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The IMP will be used for the identification of sentinel lymph node(s) in patients with parotid gland carcinoma. MedDRA version: 21.1 Level: LLT Classification code 10026329 Term: Malignant neoplasm of parotid gland System Organ Class: 100000004864 MedDRA version: 20.0 Level: LLT Classification code 10072873 Term: Sentinel lymph node mapping System Organ Class: 100000004848 MedDRA version: 20.1 Level: LLT Classification code 10073554 Term: Sentinel node biopsy System Organ Class: 100000004848

Interventions

Product Name: [68Ga]Ga-Tilmanocept Product Code: V09IA009 Pharmaceutical Form: Injection INN or Proposed INN: Tilmanocept CAS Number: 1262984-82-6 Concentration unit: MBq megabecquerel(s) Concentratio

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this study is to prove the concept of sentinel lymph node imaging in parotid gland carcinoma using preoperative 68-galium-tilmanocept PET/CT combined with intraoperative gamma probe and fluorescence camera localization. The number of visualized and resected sentinel lymph node(s) will be assessed.;Secondary Objective: •To compare histopathologic results (presence or absence of isolated tumor cells and (micro-)metastasis) of the excised sentinel lymph node(s), and eventual complementary 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.;Primary end point(s): The primary endpoint of this study is the feasibility and validation of the sentinel node biopsy procedure in patients with carcinoma of the parotid gland with N0 neck scheduled for parotidectomy with elective neck dissection, using preoperative 68-galium-tilmanocept PET/CT combined with intraoperative gamma probe and fluorescence camera localization. ;Timepoint(s) of evaluation of this end point: First a pilot study will be conducted with 10 patients to build experience with the outcomes of 68-galium-tilmanocept PET/CT in patients with parotid gland carcinoma.	—

Measure

Time frame

Main Objective: The primary objective of this study is to prove the concept of sentinel lymph node imaging in parotid gland carcinoma using preoperative 68-galium-tilmanocept PET/CT combined with intraoperative gamma probe and fluorescence camera localization. The number of visualized and resected sentinel lymph node(s) will be assessed.;Secondary Objective: •To compare histopathologic results (presence or absence of isolated tumor cells and (micro-)metastasis) of the excised sentinel lymph node(s), and eventual complementary 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.;Primary end point(s): The primary endpoint of this study is the feasibility and validation of the sentinel node biopsy procedure in patients with carcinoma of the parotid gland with N0 neck scheduled for parotidectomy with elective neck dissection, using preoperative 68-galium-tilmanocept PET/CT combined with intraoperative gamma probe and fluorescence camera localization. ;Timepoint(s) of evaluation of this end point: First a pilot study will be conducted with 10 patients to build experience with the outcomes of 68-galium-tilmanocept PET/CT in patients with parotid gland carcinoma.

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Secondary

Measure	Time frame
Secondary end point(s): • Histopathologic results (presence or absence of isolated tumor cells and (micro-)metastasis) of the excised sentinel lymph node(s) compared to eventual complementary neck dissection specimens. • Localization and numbers of sentinel lymph nodes. • Best timing of PET/CT. • Incidence and degree of postoperative complications, graded by means of the Clavien-Dindo classification of Surgical Complications.;Timepoint(s) of evaluation of this end point: First a pilot study will be conducted with 10 patients to build experience with the outcomes of 68-galium-tilmanocept PET/CT in patients with parotid gland carcinoma.	—

Measure

Time frame

Secondary end point(s): • Histopathologic results (presence or absence of isolated tumor cells and (micro-)metastasis) of the excised sentinel lymph node(s) compared to eventual complementary neck dissection specimens. • Localization and numbers of sentinel lymph nodes. • Best timing of PET/CT. • Incidence and degree of postoperative complications, graded by means of the Clavien-Dindo classification of Surgical Complications.;Timepoint(s) of evaluation of this end point: First a pilot study will be conducted with 10 patients to build experience with the outcomes of 68-galium-tilmanocept PET/CT in patients with parotid gland carcinoma.

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Countries

Netherlands

Contacts

Public ContactClinical Trial Office

University Medical Center Utrecht

trialbureaucancercenter@umcutrecht.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026