A Novel Intraoperative Fluorescence-guided System for Evaluating Margins During Breast-conserving… (NCT07352930) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Novel Intraoperative Fluorescence-guided System for Evaluating Margins During Breast-conserving Surgery for Breast Cancer
China172 participantsStarted 2026-04-01
Plain-language summary
The goal of this clinical trial is to learn if a novel intraoperative fluorescence-guided system (EndoSCell Scanner) can help surgeons more accurately remove all cancerous tissue during breast-conserving surgery in female patients aged 18 years or older, with primary breast cancer. The main questions it aims to answer are:
* Does the use of the EndoSCell Scanner system lower the rate of secondary surgeries needed due to positive cancer margins after the initial operation?
* How accurate is the EndoSCell Scanner system in detecting residual cancer cells on the walls of the surgical cavity during the operation?
Researchers will compare the surgical outcomes using the EndoSCell Scanner guidance to the expected outcomes from standard surgical practice without this technology to see if the system is effective.
Participants will:
* Receive their planned breast-conserving surgery (lumpectomy).
* Have their surgical cavity scanned with the EndoSCell Scanner device after the main tumor is removed.
* Have additional tissue removed from the cavity wall if the scanner indicates a potential cancer residue.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. Pathologically confirmed diagnosis of primary invasive breast cancer, ductal carcinoma in situ (DCIS), or invasive breast cancer with a DCIS component. Acceptable diagnostic methods include core needle biopsy or fine-needle aspiration biopsy.
✓. Female, age ≥ 18 years.
✓. Scheduled to undergo breast-conserving surgery for the malignant breast lesion.
✓. Willing and able to comply with the study procedures and follow-up.
✓. Has provided written informed consent.
Exclusion criteria
✕. Adequate organ and bone marrow function, defined as:
✕. ECOG performance status of 0 or 1.
✕. Pregnancy or lactation.
✕. Suspected pregnancy.
✕. Prior injection of ICG or other fluorescent dyes for sentinel lymph node mapping on the day of surgery, before the planned lumpectomy cavity scan with the study device.
What they're measuring
1
The rate of positive margins on final pathological testing
Timeframe: From the date of the initial lumpectomy (Day 0) until the receipt of the final postoperative pathology report and surgical decision, assessed up to 30 days post-surgery.
✕. Unresolved adverse events from previous medications or diagnostic agents.
✕. Uncontrolled hypertension, defined as persistent systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 110 mmHg. Patients with known hypertension must be stable on medication within these limits.
✕. History of allergy to any oral or intravenous contrast agent.