The IMP will be used for the identification of sentinel lymph node(s) in patients with early-stage oral cavity squamous cell carcinoma and a clinically negative neck (T1-3, N0, M0). 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 10004822 Term: Biopsy of lymph node System Organ Class: 100000004848 MedDRA version: 21.0 Level: LLT Classification code 10030961 Term:
Conditions
Interventions
Product Name: Gadovist
Pharmaceutical Form: Injection
INN or Proposed INN: Gadovist
CAS Number: 138071-82-6
Other descriptive name: GADOBUTROL
Concentration unit: ml millilitre(s)
Concentration type:
Sponsors
University Medical Center Utrecht
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 oral squamous cell carcinoma that is anatomically located in: mucosal lip, buccal mucosa, lower alveolar ridge, upper alveolar ridge, retromolar gingival (retromolar trigone), floor-of-the-mouth, hard palate or oral (mobile) tongue, and is stage T1-T2 and T3 (only when T3 is assessed based on tumor dimensions of >2 cm and =4 cm with DOI >10 mm), N0, M0 (see Appendix 3: TNM Staging). 3. Clinical nodal staging (N0) 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 transoral excision and sentinel lymph node biopsy. 5. The patient has given informed consent for a surgical procedure regarding his/her oncological treatment. 6. Patients with prior malignancy are allowed, provided the patient meets both of the following criteria: • Underwent potentially curative therapy for all prior head and neck malignancies and is deemed low risk for recurrence; and • No head and neck malignancy for the past five years and no evidence of recurrence. 7. The patient is =18 years of age at the time of consent. 8. The patient has an ECOG status of Grade 0 – 2 (see Appendix 4: Performance Status Criteria). 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 has a diagnosis of squamous cell carcinoma of the head and neck in the following anatomical areas: non-mobile base of the tongue, oropharynx, nasopharynx, hypopharynx, and larynx. 2. The patient is pregnant or lactating. 3. Patient is incapacitated. 4. Previous allergic reaction after administration of a gadolinium-based contrast agent for contrast enhanced MR imaging. 5. The patient has clinical or radiological evidence of metastatic cancer to the regional lymph nodes. 6. 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. 7. The patient is actively receiving systemic cytotoxic chemotherapy. 8. Patient is on immunosuppressive, anti-monocyte, or immunomodulatory therapy. 9. Patient has severe renal impairment (eGFR<30). 10. Participation will result in unacceptable delay regarding oncological treatment. 11. Patients with known claustrophobia, who are as a consequence unable to undergo MR imaging.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this pilot study is to investigate the detection rate of SLNs using MR lymphography.;Secondary Objective: • To compare the number of MR lymphography detected SLNs with those detected by means of 99mTc-nanocolloid lymphoscintigraphy on a per-subject basis. • To compare pathologic assessment (presence or absence of isolated tumor cells and (micro-)metastasis) of the excised lymph node(s)SLN(s) identified by 99mTc-nanocolloid lymphoscintigraphy and MR lymphography on a per-subject basis. • Observing contralateral drainage patterns in lateralized tumours and compare these patterns between MR lymphography and 99mTc nanocolloid lymphoscintigraphy, especially in case of a positive sentinel node. • To assess pairwise interobserver agreements between MR lymphography and 99mTc-nanocolloid lymphoscintigraphy regarding preoperative SLN detection.;Primary end point(s): The main outcome measure is the detection rate of sentinel lymph nodes with MR lymphography, compared to conventional lymphoscintigraphy with 99mTc nanocolloid and histopathological examination as the reference standard.;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 MR lymphography in patients with early-stage oral cavity squamous cell carcinoma. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • To compare the number of MR lymphographic detected SLNs with those detected by means of 99mTc-nanocolloid lymphoscintigraphy on a per-subject basis. • To compare histopathologic assessment (presence or absence of metastasis) of the excised lymph node(s) detected by conventional preoperative 99mTc-nanocolloid lymphoscintigraphy and intraoperative gammaprobe localization, with the SLNs identified by means of preoperative MR lymphography. • Observing contralateral drainage patterns in lateralized tumors and compare these patterns between MR lymphography and conventional 99mTc-nanocolloid lymphoscintigraphy. • To assess pairwise inter-observer agreements between MR lymphography and conventional 99mTc-nanocolloid lymphoscintigraphy regarding preoperative SLN detection.;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 MR lymphography in patients with early-stage oral cavity squamous cell carcinoma. | — |
Countries
Netherlands
Contacts
Public ContactClinical Trial Office
University Medical Center Utrecht
Outcome results
None listed