Clinical trial · Interventional
CLI and FAR for Intraoperative Margin Assessment
Intraoperative Assessment of Tumour Excision Margins Using the LightPath Imaging System for Cerenkov Luminescence Imaging (CLI) Combined With Flexible Autoradiography (FAR) in Women Undergoing Breast-conserving Surgery (BCS)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is a prospective, single arm interventional study to evaluate the diagnostic accuracy of intraoperative Cerenkov luminescence imaging (CLI) plus flexible autoradiography (FAR) using the LightPath® Imaging System for intraoperative tumour margin assessment compared to post-operative standard-of-care histopathology in women undergoing breast-conserving surgery for breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Female | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intraoperative CLI + FAR LightPath imaging | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Breast Cancer undergoing BCS
- description
- Intraoperative CLI + FAR LightPath imaging compared with Standard-of-care histopathology (gold standard)
- interventionNames
- Procedure: Intraoperative CLI + FAR LightPath imaging
Primary outcomes (1)
- measure
- Margin status of WLE specimens
- timeFrame
- complete surgical procedure
- description
- The resection margin status of the WLE specimen and cavity shavings (if any), as assessed by LightPath CLI + FAR imaging will be compared with final histopathology results. A positive margin on histology will be defined as * Invasive carcinoma: positive: \<1mm; negative ≥1mm * Ductal carcinoma in situ (DCIS) (if present): positive: \<2mm; negative ≥2mm. The resection margin status of the WLE specimen and cavity shavings (if any), as assessed by LightPath CLI + FAR imaging will be compared with final histopathology results. A positive margin on histology will be defined as * Invasive carcinoma: positive: \<1mm; negative ≥1mm * Ductal carcinoma in situ (DCIS) (if present): positive: \<2mm; negative ≥2mm.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * • Female subjects ≥18 years of age with a diagnosis of invasive breast cancer scheduled to undergo BCS * 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 of childbearing age must have a negative pregnancy test (by Beta human chorionic gonadotrophin (β-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 have had surgery to the ipsilateral breast in the past 12 months * Subjects who have had radiotherapy to the ipsilateral breast * Subjects who have a known hypersensitivity to 18F-FDG * Subjects who are pregnant or lactating * Subjects who have an existing medical condition that would compromise their participation in the study
References
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