An interventional study of Histolog® Scanner in Breast Cancer, Ductal Carcinoma In Situ and Invasive Lobular Carcinoma, sponsored by Hôpital du Valais. Not yet recruiting at 1 site in Switzerland. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-14.
Sponsored by Hôpital du Valais · Not applicable, Interventional, and Diagnostic
Among 232 studies in Breast Neoplasms with a site in Switzerland — 32 open to participants now, 64 under way, 24 of them phase 3. Breast Neoplasms · Switzerland.
Among the 232 studies in Breast Neoplasms with a site in Switzerland, this one is the 103rd largest by planned enrollment of the 188 interventional ones that give a count, is one of 7 that started in 2026, is one of 40 with no phase, reaches primary completion later than 55 of the 63 other live ones, and was the 227th registered.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
Browse Breast Neoplasms studies →32 of the 232 studies in Breast Neoplasms with a site in Switzerland are open now. Recruiting first, the newest first:
Isabell Xiang Ge · Sites in Switzerland
Ages 18+ · Women only
AstraZeneca · Sites in Switzerland, United States, France and 6 more countries
Ages 18–130
University Hospital, Basel, Switzerland · Sites in Switzerland
University Hospital, Basel, Switzerland · Sites in Switzerland, United States, Austria and 8 more countries
Ages 18+
University of Bern · Sites in Switzerland
Ages 18+
A study can be open while its sites in Switzerland have not opened yet or have stopped. Only those recruiting at a site in Switzerland →
Of the 2,400 Breast Neoplasms studies recruiting now, 1,572 (66%) set no upper age limit and 591 (25%) stop at 75 or younger; 103 take children under 18; 214 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
232 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 24 · Phase 2 47 · Phase 3 87 · Phase 4 3
First in 1993; this study’s year is marked. 7 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 228 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Median enrollment 262 across the 188 interventional studies, 264 across the 41 observational. Of the 154 that completed or were terminated, 64 (42%) have results posted.
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104 of 232 have an industry lead sponsor. The 10 most frequent:
Hôpital du Valais is the lead sponsor of 15 studies on the registry; 3 are open to participants now.
Hôpital du Valais has 2 studies filed under Breast Neoplasms — fewer than ten, so there is no comparison to draw.
13 of the studies in Breast Neoplasms with a site in Switzerland that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03820830Phase 3ETOP IBCSG Partners FoundationPalbociclib for HR Positive / HER2-negative Isolated Locoregional Recurrence of Breast Cancer | 2026-12 |
| NCT05909397Phase 3PfizerVepdegestrant (ARV-471/PF-07850327) + Palbociclib vs Letrozole + Palbociclib in ER(+)/HER2(-) Advanced Breast Cancer | 2026-12-30 |
| NCT06312176Phase 3Merck Sharp & Dohme LLCA Study of Sacituzumab Tirumotecan (MK-2870) as a Single Agent and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer (MK-2870-010) | 2027-07-11 |
| NCT06085833ARTIDIS AGARTIDIS Nanomechanical Generated Measurements for Early Breast Lesions | 2026-12 |
| NCT07398079University Hospital, Basel, SwitzerlandPilot Observational Study of an Integrative Cure Stay Program | 2026-12 |
Among the 232 studies in Breast Neoplasms with a site in Switzerland, from their registry updates:
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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.
BACKGROUND Breast cancer is the most common cancer in women in Switzerland, with approximately 6,500 new cases annually. Breast-conserving surgery (BCS, lumpectomy) is the preferred surgical approach for localised tumours and achieves equivalent survival outcomes to mastectomy when negative margins are obtained. However, re-excision rates of 20-30% have been reported in unselected BCS populations.
The risk of positive margins is particularly elevated in specific histological subtypes: published data indicate a relative risk of positive margins of 2.21 for ductal carcinoma in situ (DCIS) and 1.44 for invasive lobular carcinoma (ILC) compared to NST carcinoma without in situ component. A retrospective analysis of 266 consecutive eligible BCS cases at CHVR (2021-2024) identified a reoperation rate of 11.3% (30/266). A prospective study in the literature reported a reduction from 30% to 10% when intraoperative histological scanning was added to standard of care.
DEVICE The Histolog® Scanner (SamanTree Medical SA, Lausanne; CE IVD Class A, UDI 764017998003GV, software v3.4.0) enables real-time confocal fluorescence imaging of fresh lumpectomy specimen surfaces ex vivo, without tissue processing or staining, providing H\&E-quality images intraoperatively. The device is already in routine clinical use at CHVR.
STUDY OBJECTIVE To evaluate whether systematic use of the Histolog® Scanner in addition to standard of care reduces the reoperation rate by 50% or more - from 11.3% to ≤5.6% - in patients with ILC, pure DCIS, or NST+DCIS undergoing BCS at CHVR.
STUDY DESIGN Prospective, single-arm, single-centre post-market performance follow-up (PMPF) study (IVDR 2017/746). Comparator: validated historical institutional control (CHVR 2021-2024, same surgical team, n=266, reoperation rate 11.3%). A randomised design was not ethically justifiable as the device is already in routine use at CHVR.
PROCEDURE Following lumpectomy, the fresh specimen undergoes standard palpation then systematic Histolog® Scanner imaging (ex vivo, on the specimen surface). At the surgeon's discretion, standard radiological assessment is also performed. Intraoperative recuts are decided based on combined standard of care and Histolog® Scanner findings. The specimen is sent to the institutional pathology laboratory (ICH-CHVR) for definitive histopathology. The primary endpoint (reoperation recommendation) is determined by the multidisciplinary tumour board based on final histopathology, independently of intraoperative findings.
OUTCOMES Primary: reoperation rate (proportion of patients for whom the tumour board recommends re-excision), assessed within 4 weeks of BCS.
Secondary: (1) subgroup reoperation rates (ILC, pure DCIS, NST+DCIS); (2) intraoperative recut rate and localisation; (3) cost analysis; (4) exploratory concordance between intraoperative and final pathological margin status.
ELIGIBILITY Inclusion: women ≥18 years; CNB/VAB confirming ILC, pure DCIS, or NST+DCIS; planned BCS at CHVR; signed eIC.
Exclusion: pregnancy; prior neo-adjuvant treatment; mastectomy indication; acriflavine hypersensitivity; incapacity to consent.
SAMPLE SIZE n=228 patients (205 evaluable minimum; 10% dropout). Calculated by one-sample z-test (Fleiss 1981): α=0.05 two-sided, power=80%, p₀=11.3%, p₁=5.6%. Estimated recruitment: 3-3.5 years.
STATISTICAL ANALYSIS Primary: one-sample z-test for a proportion (two-sided, α=0.05), per-protocol population, with exact 95% Clopper-Pearson CI. Pass criterion: p\<0.05 and observed rate ≤5.6%. Sensitivity analysis on ITT population. No interim analysis planned.
ETHICAL / REGULATORY Category A1 (ClinO-MD Art. 6a). CEC: Commission cantonale d'éthique du Valais (CCVS). No Swissmedic approval required. Electronic informed consent (eIC). Declared conflict of interest: PI holds a consultancy arrangement with SamanTree Medical SA (institutional fee); mitigation: independent tumour board endpoint, independent biostatistician.
FUNDING Institutional budget of CHVR. No industry funding.
Pre-operative core needle (CNB) or vacuum-assisted biopsy (VAB) with histological diagnosis of one of the following:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Histolog® Scanner
CE-marked Class A IVD confocal fluorescence microscopy device (SamanTree Medical SA, Lausanne, Switzerland; UDI 764017998003GV; software v3.4.0). Used intraoperatively to image the surface of the fresh lumpectomy specimen ex vivo, without tissue processing or staining, providing real-time histological-quality margin assessment. Accessories: Histolog Dish (UDI 764017998004GX) and Histolog Dip fluorescent staining solution (UDI 764017998005GZ).
Also known as: Histolog Scanner
Reoperation Rate
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).
Time frame: Within 4 weeks after breast-conserving surgery
Reoperation rate
Proportion of patients requiring reoperation within each histological subgroup: (1) invasive lobular carcinoma (ILC), (2) pure ductal carcinoma in situ (DCIS), (3) invasive NST carcinoma with DCIS component (NST+DCIS).
Time frame: Within 4 weeks after breast-conserving surgery
Intraoperative recut rate
Proportion of cases requiring at least one intraoperative recut, with distinction between recuts indicated by standard of care versus recuts additionally indicated by Histolog Scanner findings. Localisation recorded (cranial, medial, caudal, lateral).
Time frame: Intraoperative
Cost analysis
Estimated cost differential between the prospective study group and the historical control group, accounting for the cost of reoperations avoided and the cost of Histolog Scanner use per procedure.
Time frame: At study completion, approximately 3.5 years
Concordance between intraoperative and final pathological margin assessment
Exploratory analysis of sensitivity and specificity of intraoperative Histolog Scanner margin assessment versus definitive histopathological margin status, where data are available for at least 80% of cases.
Time frame: Within 4 weeks after breast-conserving surgery
Plan to share: No — This is a single-centre post-market performance follow-up (PMPF) study with a limited sample size (n=228). No individual participant data (IPD) sharing is planned. Aggregate results will be published in a peer-reviewed journal and reported in ClinicalTrials.gov and BASEC upon study completion.
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Mar 2030, 42 months later.
Of 2,661 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's planned 42 months is above that.
Counting every sponsor, half of 2,771 studies reached it within 33 months; a quarter within 15 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Hôpital du Valais