Using advanced imaging to assess tumor margins during breast cancer surgery
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)
PHASE2 · King's College London · NCT05496101
This study is testing a new imaging technique during breast cancer surgery to see if it helps doctors find and remove all cancerous tissue more effectively than the usual methods.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | King's College London (other) |
| Locations | 1 site (London) |
| Trial ID | NCT05496101 on ClinicalTrials.gov |
What this trial studies
This interventional study evaluates the effectiveness of intraoperative Cerenkov luminescence imaging (CLI) combined with flexible autoradiography (FAR) for assessing tumor margins in women undergoing breast-conserving surgery for breast cancer. The LightPath® Imaging System will provide real-time imaging to help surgeons identify cancerous tissue at the margins of excised specimens. If cancer is detected at the margins, additional tissue can be removed during surgery to ensure complete tumor excision. The results from this imaging will be compared to standard post-operative histopathology to determine accuracy.
Who should consider this trial
Good fit: Ideal candidates are female patients aged 18 and older diagnosed with invasive breast cancer scheduled for breast-conserving surgery.
Not a fit: Patients who have had prior surgery or radiotherapy to the same breast within the last 12 months may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more precise surgeries and reduce the need for additional procedures due to incomplete tumor removal.
How similar studies have performed: While this approach is innovative, similar imaging techniques have shown promise in other surgical contexts, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
London
- Guy's and St Thomas NHS Trust — London, United Kingdom (RECRUITING)
Study contacts
- Study coordinator: Arnie Purushotham
- Email: Arnie.purushotham@kcl.ac.uk
- Phone: 0207188188
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer Female