Evaluation of the LightPath Imaging System and the PET tracer 68Ga-RM2 in wide local excision (WLE) for breast cancer

ightpoint Medical Ltd0 个研究点目标入组 80 人开始时间: 2018年6月29日最近更新: 2024年9月9日

适应症

试验速览

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•Subjects who have signed an informed consent form prior to any study related activity
•Subjects who are able to give voluntary, written informed consent to participate in this study.
•Subjects who are able to understand this study and are willing to complete all the study assessments
•Female subjects =18 years of age with a diagnosis of ER-positive invasive breast cancer. ER-positivity is defined as an Allred score of 3 or more on immunohistochemical analysis.
•Female subjects of childbearing age must have a negative pregnancy test (by Beta human chorionic gonadotrophin qualitative analysis), or must have had a history of a surgical sterilisation, or must give history of no menses in the past twelve months
•Groups 2 and 3: Subjects scheduled for WLE (+/- SLNB or ALND)
•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 50
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 30

•Subjects who have had surgery in the operated breast in the past 12 months
•Subjects who have had radiotherapy in the operated breast
•Subjects who have had neoadjuvant systemic therapy
•Subjects who have had systemic chemotherapy or investigational therapy in the past two years
•Subjects who are pregnant or lactating
•Subjects who have an existing medical condition that would compromise their participation in the study
•Subjects with a current or active history of other known cancer in the opinion of the Investigator

发起方

ightpoint Medical Ltd