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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)

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-514233-37-00
Enrollment
10
Registered
2024-07-12
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-12

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

Conditions

Carcinoma of the parotid gland

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

Universitair Medisch Centrum Utrecht
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026