Oral cavity cancer
Conditions
Interventions
None
Sponsors
University Medical Center Utrecht
Eligibility
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 dimen-sions of >2 cm and =4 cm with DOI >10 mm), N0, M0 (see Appendix 6: TNM Staging). 3. Clinical nodal staging (N0) has been confirmed by negative results from ultrasound guid-ed fine needle aspiration cytology within 30 days of the SLN procedure. 4. The patient is a candidate for transoral excision. 5. Patients with prior malignancy of the head and neck area are allowed, provided the pa-tient 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. 6. The patient is =18 years of age at the time of consent. 7. The patient has an ECOG status of Grade 0 – 2 (see Appendix 7: Performance Status Criteria).
Exclusion criteria
Exclusion criteria: 1. The patient has a diagnosis of squamous cell carcinoma of the head and neck in the fol-lowing 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 tracer. 4. The patient has had other nuclear imaging studies, conducted within 10 days (240 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 therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The diagnostic accuracy, in terms of sensitivity and negative predictive value, of 68Ga-Tilmanocept PET/CT combined with conventional lymphoscintigraphy for sentinel lymph node biopsy in early-stage oral cavity cancer. The diagnostic accuracy, in terms of sensitivity and negative predictive value, for preoperative 68Ga-Tilmanocept PET/CT alone as compared to conventional preoperative lymphoscintigraphy alone. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Preoperative SLN detection rate using 68Ga-Tilmanocept PET/CT as com-pared to conventional lymphoscintigraphy. • Comparison of histopathologic results (presence or absence of metastasis) of the excised sentinel lymph node(s), and eventual complementary neck dissection specimens, detected by conventional preoperative 99mTc-Tilmanocept lymphoscintigraphy and intraoperative gamma probe localiza-tion, with the SLNs identified by means of preoperative 68Ga-Tilmanocept PET/CT. • Observing contralateral drainage patterns in lateralized tumors and compari-son of these patterns between 68Ga-Tilmanocept PET/CT lymphoscintigra-phy and 99mTc-Tilmanocept conventional lymphoscintigraphy, especially in case of a histopathological positive sentinel node. • Pairwise inter-observer agreements between by 68Ga-Tilmanocept PET/CT lymphoscintigraphy and 99mTc-Tilmanocept | — |
Contacts
Public ContactRutger Mahieu
University Medical Center Utrecht
Outcome results
None listed