Mouth cancer occult lymph node metastasis
Conditions
Interventions
Patients will undergo additional PET/CT imaging following peritumoral
injections of 10 MBq 68Ga-Tilmanocept. Results of 68Ga-Tilmanocept PET/CT
imaging will be compared to results of conventional ly
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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 10 mm), N0, M0 (see Appendix 6: TNM Staging). 4. Clinical nodal staging (N0) has been confirmed by negative results from ultrasound guided fine needle aspiration cytology within 30 days of the SLN procedure. 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
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 therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The sensitivity and negative predictive value of 68Ga-Tilmanocept PET/CT combined with conventional lymphoscintigraphy for SLNB. Furthermore, the sensitivity and negative predictive value for preoperative 68Ga-Tilmanocept PET/CT alone will be compared with conventional preoperative lymphoscintigraphy alone. | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the number of 68Ga-Tilmanocept PET-CT detected SLNs with those detected by means of 99mTc-Tilmanocept 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-Tilmanocept lymphoscintigraphy and intraoperative gammaprobe localization, with the SLNs identified by means of preoperative 68Ga-Tilmanocept PET-CT. Observing contralateral drainage patterns in lateralized tumors and compare these patterns between of 68Ga-Tilmanocept PET-CT and 99mTc-Tilmanocept lymphoscintigraphy, especially in case of a histopathological positive sentinel node. To assess pairwise inter-observer agreements between 68Ga-Tilmanocept PET-CT and 99mTc-Tilmanocept lymphoscintigraphy regarding preoperative SLN detection. | — |
Countries
Netherlands
Outcome results
None listed