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NCT07527468: HISMAR
HISMAR: Intraoperative Margin Assessment Using the Histolog® Scanner to Reduce Reoperation in Breast-Conserving Surgery
NA trial testing Histolog® Scanner in Breast Cancer in 228 participants. Not yet recruiting.
1 March 2030
Quick facts
| Lead sponsor | Hôpital du Valais |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 228 |
| Start date | 1 September 2026 |
| Primary completion | 1 March 2030 |
| Estimated completion | 1 June 2030 |
| Sites | 1 location across Switzerland |
Drugs / interventions tested
- Histolog® Scanner
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
- Ductal Carcinoma In Situ — all drugs for Ductal Carcinoma In Situ →
- Invasive Lobular Carcinoma — all drugs for Invasive Lobular Carcinoma →
- Breast Neoplasm Female — all drugs for Breast Neoplasm Female →
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.
Verify or expand the search:
- PubMed search for NCT07527468
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07527468 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hôpital du Valais
- Last refreshed: 14 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07527468.
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