Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
10
Countries
1
Sites
1
Carcinoma of the parotid gland
To evaluate the feasibility and prove the concept of sentinel lymph node biopsy (SLNB) in patients with carcinoma of the parotid gland and scheduled for parotidectomy and elective neck dissection.
Key facts
- Sponsor
- Universitair Medisch Centrum Utrecht
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical,Diagnostic,Therapeutic Techniques and Equipment [E]-Surgical Procedures, Operative [E04]
- Trial duration
- 12 Jul 2024 → ongoing
- Decision date (initial)
- 2024-07-12
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-514233-37-00
- EudraCT number
- 2021-003068-28
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Efficacy, Diagnosis, Safety
To evaluate the feasibility and prove the concept of sentinel lymph node biopsy (SLNB) in patients with carcinoma of the parotid gland and scheduled for parotidectomy and elective neck dissection.
Secondary objectives 1
- 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
Conditions and MedDRA coding
Carcinoma of the parotid gland
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10026329 | Malignant neoplasm of parotid gland | 10029104 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- 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
- 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.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 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 endpoints 1
- 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
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
SUB170788 · Substance
- Active substance
- Gallium (68GA) Chloride
- Pharmaceutical form
- RADIONUCLIDE GENERATOR
- Route of administration
- PERITUMORAL USE
- Max daily dose
- 10 MBq megabecquerel(s)
- Max total dose
- 10 MBq megabecquerel(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB119775 · Substance
- Active substance
- Tilmanocept
- Pharmaceutical form
- KIT FOR RADIOPHARMACEUTICAL PREPARATION
- Route of administration
- PERITUMORAL USE
- Max daily dose
- 0.05 mg milligram(s)
- Max total dose
- 0.05 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universitair Medisch Centrum Utrecht
- Sponsor organisation
- Universitair Medisch Centrum Utrecht
- Address
- Heidelberglaan 100
- City
- Utrecht
- Postcode
- 3584 CX
- Country
- Netherlands
Scientific contact point
- Organisation
- Universitair Medisch Centrum Utrecht
- Contact name
- Dr. B. de Keizer
Public contact point
- Organisation
- Universitair Medisch Centrum Utrecht
- Contact name
- Dr. B. de Keizer
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 10 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Universitair Medisch Centrum Utrecht
Imaging and Oncology, Heidelberglaan 100, 3584 CX, Utrecht
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Netherlands | 2024-07-12 | 2024-07-12 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-04 | Netherlands | Acceptable with conditions 2024-07-12
|
2024-07-12 |