This study has been transitioned to CTIS with ID 2024-514233-37-00 check the CTIS register for the current data. To evaluate the feasibility and prove the concept of sentinel node biopsy in patients with carcinoma of the parotid gland and scheduled…
ID
Source
Brief title
Condition
- Head and neck therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint of this study is the feasibility 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.
Secondary outcome
• To compare histopathologic results (presence or absence of isolated tumor
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.
Background summary
In patients with carcinoma of the parotid gland the management of the
clinically negative neck is a controversial issue. In most patients a selective
(L I-III) neck dissection is performed wit associated morbidity. However, a
substantial number of these elective neck dissections are futile. The current
diagnostic techniques are not accurate enough to detect occult lymph node
metastases. The sentinel node procedure may be useful to acurately select
patients for neck dissection. So, overtreatment of the clinically negative neck
will be reduced in the future, as only the patients with positive sentinel
lymph node(s) will be eligible for elective neck node dissection.
Study objective
This study has been transitioned to CTIS with ID 2024-514233-37-00 check the CTIS register for the current data.
To evaluate the feasibility and prove the concept of sentinel node biopsy in
patients with carcinoma of the parotid gland and scheduled for parotidectomy
and elective neck dissection.
Study design
The proposed study is an observational, non-randomized feasibility study and
will be conducted at UMC Utrecht.
Study burden and risks
Sentinel node biopsy is a procedure which is used routinely in other head and
neck carcinomas. In the literature on head and neck cancer no serious adverse
events have been reported using these techniques. Sentinel node biopsy will be
performed by experienced head and neck surgeons during surgery of the primary
tumor. Neck dissection in combination with sentinel node biopsy stages the neck
more accurately (by detecting micrometastases and single tumor cells which may
be missed during routine examination of lymph nodes) than neck dissection
alone. Findings from this feasibility study may have implications for future
treatment planning.
Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EU-CTR | CTIS2024-514233-37-00 |
| EudraCT | EUCTR2021-003068-28-NL |
| CCMO | NL77946.041.21 |