Clinical trial · Interventional
Lidocaine Mucilage-ICG as an Optical Agent for Tumor Delineation During Breast-conserving Surgery
Evaluation of the Feasibility and Efficacy of Lidocaine Mucilage-ICG as an Optical Agent to Detect Cancer Tissue Delineation During Breast-conserving Surgery
- 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)
Around 15%-30% of patients receiving breast-conserving surgery (BCS) for invasive breast carcinoma or ductal carcinoma in situ (DCIS) need a reoperation due to tumor-positive margins at final histopathology. Currently available modalities used for intraoperative surgical margin assessment all have specific limitations. In order to improve intraoperative tumor localization and surgical margin assessment in BCS, we developed a fluorescent tracer, the Lidocaine mucilage-ICG tracer, which could be locally injected and detected by fluorescent camera systems during operation. In this study, we aim to evaluate the efficacy of Lidocaine mucilage-ICG as an agent for intraoperative tumor delineation.
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 |
|---|---|---|---|
| Lidocaine mucilage-ICG | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Efficacy of Lidocaine mucilage-ICG
- description
- Efficacy of Lidocaine mucilage-ICG for intraoperative tumor delineation
- interventionNames
- Drug: Lidocaine mucilage-ICG
Primary outcomes (2)
- measure
- Margin width
- timeFrame
- 7 days
- description
- The distance between tumor and margin on the gross specimen
- measure
- Positive margin rate
- timeFrame
- 7 days
- description
- The percentage of patients with a positive margin out of the participants
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female at least 18 years old * Histologically or cytologically confirmed breast carcinoma * Patients planned to receive a breast-conserving surgery * Patients received a preoperative breast magnetic resonance imaging * Informed consent form understood and signed * Patient agrees to all follow-up visits * Eastern Cooperative Oncology Group(ECOG) performance status 0 to 1 within 14 days of study entry * Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the surgery Exclusion Criteria: * Psychiatric or other condition that may interfere with the study * Known allergy or contraindication to any study drug * Patients received neoadjuvant therapies * Patients received an excision biopsy of the tumor * Breast feeding period * Pregnant (female of childbearing potential only)
References
Publications (0)
Data not yet available