Clinical trial · Interventional
The LightPath® Breast Cancer Study
A Multi-centre Clinical Study to Evaluate the LightPath® Imaging System in Wide Local Excision (WLE) for 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 is a prospective, single arm, multi-centre study to evaluate the intra-operative use of the LightPath® Imaging System for the assessment of tumour margin status compared to hospital standard of care histopathology in wide local excision (WLE) for breast cancer The intraoperative 18F-fluorodeoxyglucose (18F-FDG) LightPath® Images will be used to inform the surgeons about detectable residual cancer, in an attempt to achieve better guided cancer surgery and complete tumour excision with clear WLE resection margins. Study sites will use the local criteria considered standard of care to guide decisions to act on positive margins. In the LightPath® arm the resection margin status of the WLE specimen, cavity shavings (if any) and the metastatic status of axillary (sentinel) lymph nodes as measured with the LightPath® Imaging System will be compared with histopathology results.
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 | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LightPath® Imaging System. | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment arm
- description
- Wide local excision (WLE) for breast cancer with intra-operative use of the LightPath® Imaging System.
- interventionNames
- Device: LightPath® Imaging System.
Primary outcomes (1)
- measure
- Diagnostic performance of the LightPath® Imaging System
- timeFrame
- Initial surgery
- description
- The diagnostic performance of tumour margin assessment with the LightPath® Imaging System compared to hospital histopathology.
Secondary outcomes (5)
- measure
- The recommendation by the study site's multidisciplinary team (MDT) to re-operate at the index location (breast) within 1 to 6 weeks post-initial surgery according to local practice.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects who have signed an informed consent form prior to any study related activity * 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 participants ≥18 years of age with a diagnosis of invasive breast cancer * Subjects who have disease in one quadrant of the breast, not including the nipple * Subjects scheduled for WLE for breast cancer +/- SLNB or ALND. * Females of childbearing age must have a negative pregnancy test (by Beta human chorionic gonadotropin (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 with pure DCIS or with pleomorphic LCIS * Subjects who have had surgery in the ipsilateral breast in the past 12 months * Subjects who have had radiotherapy in the ipsilateral breast * Subjects who have had neoadjuvant systemic therapy * Subjects who have had systemic chemotherapy in the past two years * Subjects with a non-palpable lesion scheduled to have radio guided occult lesion localisation (ROLL) * Subjects who have 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 * Subjects who have participated in a clinical study in the last 2 months * Subjects with a current or active history of other known cancer
References
Publications (1)
- DERIVEDJurrius PAGT, Grootendorst MR, Krotewicz M, Cariati M, Kothari A, Patani N, Karcz P, Nagadowska M, Vyas KN, Purushotham A, Turska-d'Amico M. Intraoperative [18F]FDG flexible autoradiography for tumour margin assessment in breast-conserving surgery: a first-in-human multicentre feasibility study. EJNMMI Res. 2021 Mar 18;11(1):28. doi: 10.1186/s13550-021-00759-w. PMID 33738563