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NCT07527468: HISMAR

HISMAR: Intraoperative Margin Assessment Using the Histolog® Scanner to Reduce Reoperation in Breast-Conserving Surgery

Not yet recruiting NA Last updated 14 April 2026
What this trial tests

NA trial testing Histolog® Scanner in Breast Cancer in 228 participants. Not yet recruiting.

Timeline
1 September 2026
Primary endpoint
1 March 2030
1 June 2030

Quick facts

Lead sponsorHôpital du Valais
PhaseNA
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposediagnostic
Enrollment228
Start date1 September 2026
Primary completion1 March 2030
Estimated completion1 June 2030
Sites1 location across Switzerland

Drugs / interventions tested

Conditions studied

Sponsor

Hôpital du Valais — full company profile →

Who can join

18 and older, female only, with Breast Cancer or Ductal Carcinoma In Situ. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Breast Cancer

Currently open trials in the same condition.

Other Hôpital du Valais trials

Trials by the same sponsor.

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Data sources for this page

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