Clinical trial · Interventional
HISMAR: Intraoperative Margin Assessment Using the Histolog® Scanner to Reduce Reoperation in Breast-Conserving Surgery
HISMAR: A Prospective Post-Market Performance Follow-up Study of the Histolog Scanner for Intraoperative Margin Assessment in Breast-Conserving Surgery for High-Risk Histological Subtypes (ILC, DCIS, NST+DCIS)
- 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 evaluates whether systematic intraoperative margin assessment using the Histolog® Scanner - a confocal fluorescence microscopy device - reduces the need for reoperation after breast-conserving surgery (lumpectomy) in women with lobular carcinoma (ILC), ductal carcinoma in situ (DCIS), or invasive carcinoma with a DCIS component (NST+DCIS). After lumpectomy, the fresh specimen is imaged in real time by the surgeon using the Histolog® Scanner, which produces histological-quality images of the specimen surface without any tissue processing. This allows immediate assessment of surgical margins in the operating room, enabling the surgeon to perform additional tissue removal if needed before closing. Based on institutional data from 266 cases at CHVR (2021-2024), the current reoperation rate in this population is 11.3%. The study tests whether systematic use of the Histolog® Scanner in addition to standard care reduces this rate by 50% or more (to ≤5.6%). A total of 228 patients will be enrolled prospectively at the Centre Hospitalier du Valais Romand (CHVR), Sion, Switzerland. The reoperation decision is made by the multidisciplinary tumour board based on final histopathology results, independently of the intraoperative findings.
Conditions
Conditions (4)
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 |
| Breast Neoplasm Female | — | UNRESOLVED | — |
| Ductal Carcinoma In Situ | Breast Ductal Carcinoma In Situ | ALIAS | 0.90 |
| Invasive Lobular Carcinoma | Invasive Breast Lobular Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Histolog® Scanner | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Histolog® Scanner + Standard of Care
- description
- Patients undergo breast-conserving surgery (BCS) with systematic intraoperative margin assessment using the Histolog® Scanner in addition to standard of care (palpation, specimen radiography at surgeon's discretion). Intraoperative recuts are decided based on combined standard of care and Histolog® Scanner findings. The reoperation decision is made by the multidisciplinary tumour board based on final histopathology, independently of intraoperative findings.
- interventionNames
- Device: Histolog® Scanner
Primary outcomes (1)
- measure
- Reoperation Rate
- timeFrame
- Within 4 weeks after breast-conserving surgery
- description
- Proportion of enrolled patients for whom the multidisciplinary tumour board recommends re-excision surgery following definitive histopathological analysis of the lumpectomy specimen. The outcome is binary (reoperation: yes/no). Compared against the historical institutional control rate of 11.3% (CHVR 2021-2024, n=266).
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
1. Female patient, aged 18 years or older at time of surgery. 2. Pre-operative core needle biopsy (CNB) or vacuum-assisted biopsy (VAB) with histological diagnosis of one of the following: 1. invasive lobular carcinoma (ILC/CLI), 2. pure ductal carcinoma in situ (DCIS), or 3. invasive carcinoma of non-special type (NST) with an associated DCIS component. 3. Planned breast-conserving surgery (BCS / lumpectomy) at CHVR. 4. Signed electronic informed consent (eIC) obtained prior to any study procedure. Exclusion Criteria: 1. Pregnancy (confirmed or suspected) at time of surgery. 2. Prior neo-adjuvant treatment (hormonal therapy or chemotherapy) for the current breast cancer diagnosis. 3. Surgical indication for mastectomy rather than BCS. 4. Known hypersensitivity or allergy to acriflavine (fluorescent staining agent used with the Histolog Scanner). 5. Incapacity to provide informed consent. 6. Previous enrolment in this study.
References
Publications (0)
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