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Sentinel lymph node (SLN) detection in early oral cancer using Gallium-68-Tilmanocept PET/CT.
EU CTIS ID: 2025-521682-27-00
What this study is testing
The primary objective of this study is to assess the diagnostic accuracy, in terms of sensitivity and negative predictive value, of preoperative 68Ga-Tilmanocept PET/CT combined with conventional lymphoscintigraphy for SLN detection. Besides, we aim to compare the diagnostic accuracy of preoperative 68Ga-Tilmanocept PET/CT alone with conventional preoperative lymphoscintigraphy alone.
- Phase III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- The patient has provided written informed consent authorization before participating in the study.
- 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.
- 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 Staging).
- Clinical nodal staging (N0) has been confirmed by negative results from ultrasound guided fine needle aspiration cytology within 30 days of the SLN procedure.
- The patient is a candidate for transoral excision.
- 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.
You likely can't join if
- 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.
- The patient is incapacitated.
- The patient has had a previous allergic reaction after administration of a radionuclide tracer.
- The patient has had other nuclear imaging studies, conducted within 2 days (48 hours) of injection.
- The patient has clinical or radiological evidence of metastatic cancer to the regional lymph nodes.
- 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.
See the full eligibility criteria
- The patient has provided written informed consent authorization before participating in the study.
- 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.
- 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 Staging).
- Clinical nodal staging (N0) has been confirmed by negative results from ultrasound guided fine needle aspiration cytology within 30 days of the SLN procedure.
- The patient is a candidate for transoral excision.
- 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.
- The patient is ≥18 years of age at the time of consent.
- The patient has an ECOG status of Grade 0 – 2 (see Appendix 7: Performance Status Criteria).
- 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.
- The patient is incapacitated.
- The patient has had a previous allergic reaction after administration of a radionuclide tracer.
- The patient has had other nuclear imaging studies, conducted within 2 days (48 hours) of injection.
- The patient has clinical or radiological evidence of metastatic cancer to the regional lymph nodes.
- 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.
- The patient is actively receiving systemic cytotoxic chemotherapy.
- The patient is on immunosuppressive, anti-monocyte, or immunomodulatory therapy.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.