A randomised, controlled, multi-centre clinical study to evaluate the outcomes following the intra-operative use of the LightPathTM Imaging System compared to standard practice in wide local excision (WLE) for breast cancer

ightpoint Medical Ltd0 个研究点目标入组 66 人开始时间: 2016年2月11日最近更新: 2022年5月16日

适应症

试验速览

2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33738563/ pilot study results (added 22/03/2021)

•1. Signed an informed consent form prior to any study related activity
•2. Able to give voluntary, written informed consent to participate in this study.
•3. Able to understand this study and are willing to complete all the study assessments
•4. Female subjects =18 years of age with a diagnosis of invasive breast cancer or DCIS
•5. Those who have unifocal disease in one quadrant of the breast, not including the nipple
•6. Those who have a tumour diameter of at least 10 mm (if measurable by mammography)
•7. Scheduled for WLE +/- SLNB or ALND
•8. Of childbearing age must have a negative pregnancy test (by Beta HCG qualitative analysis), or must have had a history of a surgical sterilisation, or must give history of no menses in the past twelve months

•Subjects who:
•1. Have had surgery in the operated breast in the past 2 years
•2. Have had radiotherapy in the operated breast
•3. Have had neoadjuvant systemic therapy
•4. Have had systemic chemotherapy in the past two years
•5. Not suitable for WLE
•6. Have blood glucose level =12 mmol/L
•7. Have known hypersensitivity to 18F-FDG
•8. Planned perioperative or Intraoperative Radiation Therapy (IORT) or brachytherapy
•9. Pregnant or lactating
•10. Have an existing medical condition that would compromise their participation in the study
•11. Have participated in a clinical study in the last 2 months
•12. Current or active history of other known cancer

发起方

ightpoint Medical Ltd