ISRCTN17778965
Active, not recruiting
未知
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 sites66 target enrollmentFebruary 11, 2016
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ightpoint Medical Ltd
- Enrollment
- 66
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33738563/ pilot study results (added 22/03/2021)
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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