Identification of lymphatic metastasis in patients with oral cancer by means of sentinel lymph node biopsy using Gallium-68-Tilmanocept PET-CT

Phase 1

• Conditions: The IMP will be used for the identification of sentinel lymph nodes in patients with early-stage oral squamous cell carcinoma and a clinically negative neck (T1-3N0M0).; MedDRA version: 20.0Level: LLTClassification code 10072873Term: Sentinel lymph node mappingSystem Organ Class: 100000004848; MedDRA version: 20.1Level: LLTClassification code 10073554Term: Sentinel node biopsySystem Organ Class: 100000004848; MedDRA version: 21.0Level: LLTClassification code 10030961Term: Oral cancer stage unspecifiedSystem Organ Class: 100000004864; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

• Registration Number: EUCTR2019-004914-32-NL
• Lead Sponsor: niversity Medical Center Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-12
• Last Update Posted: 22 June 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 94

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, and is stage 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).
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 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.
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).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 62
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 32

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 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 trac-er.
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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified