Clinical trial · Interventional
The Breast Surgery EnLight and LightPath Imaging System Study
A Pilot Study to Evaluate Molecular Imaging Using a BetaScope and a Specimen Analyser for Determining Margin and Lymph Node Status During Breast Conserving Surgery in Women With Breast Cancer
- 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 will correlate the resection margin status of the breast cancer tumour (WLE specimen), cavity shavings (if any) and breast cavity, and the metastatic status of axillary lymph nodes as determined by EnLight, LightPath, and histopathology. This is a pilot study to assess feasibility before proceeding to a pivotal study to evaluate the use of these imaging systems in clinical practice.
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 Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EnLight | Device | — | UNRESOLVED |
| LightPath | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Breast conserving surgery
- description
- Females ≥ 30 years of age with a diagnosis of invasive breast cancer or ductal carcinoma in situ (DCIS), scheduled for BCS +/- SLNB or ALND
- interventionNames
- Device: EnLight
- Device: LightPath
Primary outcomes (1)
- measure
- Feasibility of intraoperative use of the EnLight and LightPath Imaging Systems.
- timeFrame
- Intra-operative
- description
- The objective of this study is to assess the feasibility of the EnLight and LightPath Imaging Systems for intra-operative analysis of WLE specimens, the post-resection surgical cavity, shavings (if any) and axillary lymph nodes in vivo and ex vivo. This will be assessed by examining the following secondary outcome measures
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
Show eligibility criteria text
Inclusion Criteria Females ≥ 30 years of age with a diagnosis of invasive breast cancer or DCIS Scheduled for BCS +/- SLNB or ALND Females of childbearing age must have a negative pregnancy test (by Beta HCG qualitative analysis), must have a history of surgical sterilisation, or must give history of no menses in past twelve months Exclusion Criteria Surgery or radiotherapy in the operated breast in the past 2 years Neoadjuvant systemic therapy Patients not suitable for BCS Blood glucose level ≥ 12 mmol/l on the day of surgery Known hypersensitivity to 18F-FDG Any patient who is pregnant or lactating
References
Publications (0)
Data not yet available