2025-521682-27-00暂停4 期
Sentinel lymph node (SLN) detection in early oral cancer using Gallium-68-Tilmanocept PET/CT.
Universitair Medisch Centrum Utrecht1 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2025年4月18日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 暂停
- 发起方
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
The primary objective of this study is to assess the diagnostic accuracy, in terms of sensitivity and negative predictive value, of preoperative 68Ga-Tilmanocept PET/CT combined with conventional lymphoscintigraphy for SLN detection. Besides, we aim to compare the diagnostic accuracy of preoperative 68Ga-Tilmanocept PET/CT alone with conventional preoperative lymphoscintigraphy alone.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •The patient has provided written informed consent authorization before participating in the study.
- •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.
- •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).
- •Clinical nodal staging (N0) has been confirmed by negative results from ultrasound guided fine needle aspiration cytology within 30 days of the SLN procedure.
- •The patient is a candidate for transoral excision.
- •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.
- •The patient is ≥18 years of age at the time of consent.
- •The patient has an ECOG status of Grade 0 – 2 (see Appendix 7: Performance Status Criteria).
排除标准
- •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.
- •The patient is incapacitated.
- •The patient has had a previous allergic reaction after administration of a radionuclide tracer.
- •The patient has had other nuclear imaging studies, conducted within 2 days (48 hours) of injection.
- •The patient has clinical or radiological evidence of metastatic cancer to the regional lymph nodes.
- •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.
- •The patient is actively receiving systemic cytotoxic chemotherapy.
- •The patient is on immunosuppressive, anti-monocyte, or immunomodulatory therapy.
结局指标
主要结局
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.
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.
次要结局
- 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.
研究者
Prof. dr. R. de Bree
Scientific
Universitair Medisch Centrum Utrecht
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
1 期
Identification of lymphatic metastasis in patients with oral cancer by means of sentinel lymph node biopsy using Gallium-68-Tilmanocept PET-CTEUCTR2019-004914-32-NLniversity Medical Center Utrecht94
尚未招募
3 期
Sentinel lymph node (SLN) detection in early oral cancer using Gallium-68-Tilmanocept PET/CTNL-OMON55311niversitair Medisch Centrum Utrecht94
尚未招募
不适用
Sentinel lymph node detection in early-stage oral cavity squamous cell carcinoma using computed tomographic lymphographyNL-OMON28606ot applicable94
已完成
不适用
Sentinel lymph node detection in early-stage oral cavity squamous cell carcinoma using computed tomographic lymphographyMouth canceroccult lymph node metastasis10019190NL-OMON49703niversitair Medisch Centrum Utrecht94
招募中
不适用
Sentinel lymph node detection in early oral cancer using Gallium-68-Tilmanocept PET-CTOral cavity cancerNL-OMON28967niversity Medical Center Utrecht94