Last reviewed · How we verify
NCT05946759: SHIELD
Reoperation Rate in Breast-Conserving Surgery Using Confocal Histolog® Scanner for Intraoperative Margin Assessment
NA trial testing Histolog Scanner in Breast Cancer - Ductal Carcinoma in Situ (DCIS) in 54 participants. Completed in 12 March 2024.
12 March 2024
Quick facts
| Lead sponsor | SamanTree Medical SA |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | other |
| Enrollment | 54 |
| Start date | 10 October 2023 |
| Primary completion | 12 March 2024 |
| Estimated completion | 12 March 2024 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- Histolog Scanner
Conditions studied
- Breast Cancer - Ductal Carcinoma in Situ (DCIS) — all drugs for Breast Cancer - Ductal Carcinoma in Situ (DCIS) →
- Breast-Conserving Surgery — all drugs for Breast-Conserving Surgery →
Sponsor
SamanTree Medical SA — full company profile →
Who can join
18 and older, female only, with Breast Cancer - Ductal Carcinoma in Situ (DCIS) or Breast-Conserving Surgery. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This PMPF study is proposed to evaluate in real life the reoperation rates (ROR) of breast cancer and/or DCIS surgery when including the use of the HLS in the context of breast lumpectomy margin assessment.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Re-Operation Rate for Breast Conserving Surgery Using Confocal Histolog Scanner for Intraoperative Margin Assessment-SHIELD Study.
Lux MP, Schuller Z, Heimann S, Reichert VMC, et al · · 2025 · cited 4× · PMID 40427138 · DOI 10.3390/cancers17101640
Verify or expand the search:
- PubMed search for NCT05946759
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Histolog Scanner
Trials testing the same drug.
- NCT06958991 — Confocal Histolog Scanner in Routine Breast-Conserving Surgery (CHiB) · NA · recruiting
- NCT05118568 — Assessment of Lumpectomy Margins With the Histolog Scanner in Comparison With Intraoperative Imaging Techniques · completed
- NCT04976556 — Breast Cancer Detection in Breast Surgical Specimens With the Histolog Scanner, Slide-free Confocal Microscope · completed
Other recruiting trials for Breast Cancer - Ductal Carcinoma in Situ (DCIS)
Currently open trials in the same condition.
- NCT07331506 — Validation of the Oncoliq Test for the Early Detection of Breast Cancer. · recruiting
- NCT07507890 — Endoscopic Nipple-Sparing Mastectomy Through a Single Axillary Incision in Breast Cancer · NA · recruiting
Other SamanTree Medical SA trials
Trials by the same sponsor.
- NCT05118568 — Assessment of Lumpectomy Margins With the Histolog Scanner in Comparison With Intraoperative Imaging Techniques · completed
- NCT04976556 — Breast Cancer Detection in Breast Surgical Specimens With the Histolog Scanner, Slide-free Confocal Microscope · completed
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 NCT05946759 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by SamanTree Medical SA
- Last refreshed: 21 March 2024
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/NCT05946759.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing