Sentinel lymph node (SLN) detection in early oral cancer using Gallium-68-Tilmanocept PET/CT
- Conditions
- Mouth canceroccult lymph node metastasis10019190
- Registration Number
- NL-OMON55311
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 94
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
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).
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.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The sensitivity and negative predictive value of 68Ga-Tilmanocept PET/CT<br /><br>combined with conventional lymphoscintigraphy for SLNB. Furthermore, the<br /><br>sensitivity and negative predictive value for preoperative 68Ga-Tilmanocept<br /><br>PET/CT alone will be compared with conventional preoperative lymphoscintigraphy<br /><br>alone.</p><br>
- Secondary Outcome Measures
Name Time Method <p>To compare the number of 68Ga-Tilmanocept PET-CT detected SLNs with those<br /><br>detected by means of 99mTc-Tilmanocept lymphoscintigraphy on a per-subject<br /><br>basis.<br /><br><br /><br>To compare histopathologic assessment (presence or absence of metastasis) of<br /><br>the excised lymph node(s) detected by conventional preoperative<br /><br>99mTc-Tilmanocept lymphoscintigraphy and intraoperative gammaprobe<br /><br>localization, with the SLNs identified by means of preoperative<br /><br>68Ga-Tilmanocept PET-CT.<br /><br><br /><br>Observing contralateral drainage patterns in lateralized tumors and compare<br /><br>these patterns between of 68Ga-Tilmanocept PET-CT and 99mTc-Tilmanocept<br /><br>lymphoscintigraphy, especially in case of a histopathological positive sentinel<br /><br>node.<br /><br><br /><br>To assess pairwise inter-observer agreements between 68Ga-Tilmanocept PET-CT<br /><br>and 99mTc-Tilmanocept lymphoscintigraphy regarding preoperative SLN detection.</p><br>