lymphatic metastasis Sentinel lymph node biopsy
Conditions
Interventions
The intervention consists of the Lymphoseek injection 4-11 days before the
standard procedure in the first 10 patients to compare the imaging between
Lymphoseek and Nanocoll. However, after 10 patie
lymph nodes
Lymphatic metastasis
mouth neoplasms
sentinel lymph node biopsy
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. The patient has provided written informed consent authorization before participating in the trial. 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, N0, M0 (see Appendix 3: TNM Staging). 3. Clinical nodal staging (N0) has been confirmed by negative results from ultrasound guided 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 are allowed provided the patient meets both of the following criteria: * Underwent potentially curative therapy for all prior malignancies and is deemed low risk for recurrence; and * No malignancy for the past five years (except effectively treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix effectively treated with surgery alone or lobular carcinoma in situ of the breast treated with surgery alone), 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 4: Performance Status Criteria).
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. The patient has clinical or radiological evidence of metastatic cancer to the regional lymph nodes. 5. 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. 6. The patient has had other nuclear imaging studies, including technetium 99m, conducted within 10 days (240 hours) of injection. 7. The patient is actively receiving systemic cytotoxic chemotherapy. 8. The patient is currently participating in another investigational drug trial or participated within 30 days prior to consenting. 9. Patient is on immunosuppressive, anti-monocyte, or immunomodulatory therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The most important parameter of this pilot study is to compare the preoperative radiotracer kinetics (rate of injection site clearance and rate of SLN uptake) for Lymphoseek and 99mTc-Nanocoll. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives: * To compare the number of lymphoscintigraphically detected SLNs identified by Lymphoseek and 99mTc-Nanocoll on a per-subject basis. * To compare differences in the ratio of counts between Lymphoseek and 99mTc-Nanocoll for the hottest SLN relative to the primary peritumoral injection site. * To compare patient pain tolerance (i.e., patient*s perceived level of discomfort) at the injection site for Lymphoseek and 99mTc-Nanocoll. * To compare pathologic assessment (presence or absence of metastasis) of the excised lymph node(s) identified by Lymphoseek and 99mTc-Nanocoll on a per-subject basis. * To compare the number of nodes localized at the early scan (0-4 hour) with the number of nodes localized on the late scan (20-26 hour). * Observing contralateral drainage patterns in lateralized tumors and compare these patterns between Lymphoseek and 99mTc-Nanocoll, especially in case of a positive sentinel node | — |
Countries
The Netherlands
Outcome results
None listed