An Exploratory Prospective, Open-label, Unicentric Study With Cross-over Design, Comparing Lymphoseek® vs. Albumin Nanocolloid for Image- Guided Sentinel Lymph Node Mapping in Head and Neck, Melanoma and Breast Cancer.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Nodal Concordance: proportion of lymph nodes identified by 99mTc-tilmanocept vs nanocolloidal human serum albumin by lymphoscintigraphies
研究概览
简要总结
Comparison of the concordance of albumin nanocolloid and Lymphoseek® in the detection of lymph nodes of primary and secondary stage drainage by performing two lymphogammagrams
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Histologically confirmed diagnosis of melanoma, breast cancer or head and neck cancer and candidate for surgical resection with lymph node mapping being a part of the surgical plan.
- •At least 18 years of age at the time of consent.
- •The subject is clinically node negative (cN0) at the time of screening.
- •In Melanoma Patients
- •Diagnosis of primary melanoma with sentinel node indication ( >0.8 mm Breslow thickness; clinically negative lymph nodes)
- •In Breast Cancer Patients
- •T1-T2 N0 breast cancer.
- •Patients with pure ductal carcinoma in situ (DCIS) if lymph node biopsy is part of the surgical plan.
- •In Oral cavity tumors patients
- •T1-T2 N0 oral cavity squamous cell carcinoma
排除标准
- •Pregnancy or lactation
- •Clinical or radiological evidence of metastatic cancer including palpably abnormal or enlarged lymph nodes
- •Patients that have had preoperative chemotherapy, immunotherapy or radiation therapy
- •Patients who have undergone node basin surgery of any type or radiation to the nodal basin(s) potentially draining the primary tumor
- •Patients who have undergone a wide excision for their tumor or complex reconstruction (rotation, free flap or skin graft of any type).
研究组 & 干预措施
Lymphoseek + Nanocoll
Comparison of the concordance of albumin nanocolloid and Lymphoseek® in the detection of lymph nodes of primary and secondary stage drainage by performing two lymphogammagrams
干预措施: Lymphoseek (Drug)
Lymphoseek + Nanocoll
Comparison of the concordance of albumin nanocolloid and Lymphoseek® in the detection of lymph nodes of primary and secondary stage drainage by performing two lymphogammagrams
干预措施: Nanocoll (Drug)
结局指标
主要结局
Nodal Concordance: proportion of lymph nodes identified by 99mTc-tilmanocept vs nanocolloidal human serum albumin by lymphoscintigraphies
时间窗: for at least 48 consecutive hours
number and diameter in millimeters of nodes affected identified by 99mTc-tilmanocept vs nanocolloidal
次要结局
- Time frame to ascertain the sentinel nodes(1 week)
- Concordance among early and delayed images obtained withLymphoseek® or with albumianocolloid and the SPECT/CT images.(1 week)
- Number of sentinel nodes and secondary nodes depicted(1 week)
- Tracer retention in injection site(1 week)
- Safety and tolerability of 99mTctilmanocept (Lymphoseek®)(1 week)
研究者
Anna Cruceta
Project Manager
Fundacion Clinic per a la Recerca Biomédica