NL-OMON55311Not yet recruitingPhase 3
Sentinel lymph node (SLN) detection in early oral cancer using Gallium-68-Tilmanocept PET/CT - SEAGATE study
niversitair Medisch Centrum Utrecht0 sites94 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 94
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational invasive
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •In order to be eligible to participate in this study, a subject must meet all
- •of the following 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.
- •3. Clinical TNM-stage is 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 6: TNM
- •4. Clinical nodal staging (N0) has been confirmed by negative results from
- •ultrasound guided fine needle aspiration cytology within 30 days of the SLN
- •5. The patient is a candidate for transoral excision.
- •6. Patients with prior malignancy of the head and neck area 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 7: Performance
- •Status Criteria).
Exclusion Criteria
- •A potential subject who meets any of the following criteria will be excluded
- •from participation in this study:
- •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, hy-popharynx, and larynx.
- •2. The patient is incapacitated.
- •3. The patient has had a previous allergic reaction after administration of a
- •radionuclide trac-er.
- •4. The patient has had other nuclear imaging studies, conducted within 2 days
- •(48 hours) of injection.
- •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 pre-clude reasonable surgical dissection for this trial, or
- •radiotherapy to the neck.
- •7. The patient is actively receiving systemic cytotoxic chemotherapy.
- •8. The patient is on immunosuppressive, anti-monocyte, or immunomodulatory
Investigators
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