Carcinoma of the parotid gland
Conditions
Brief summary
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.
Detailed description
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
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Netherlands