Clinical trial · Observational
Histolog Comparison to Standard Histology
Do the Results of Intra-operative Margin Assessment Correlate With the Output of Conventional Histology for Patient Undergoing Breast Conservation Surgery?
NCT04857229CI-TRIAL-00063913HiCoSHunknownClinicalTrials.gov clinicaltrialsProvenance
- 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 is a clinical device trial to assess the accuracy of margin assessment for a confocal scanning device (Histolog Scanner) at assessing the margins of breast tissue following wide local excision surgery.
Conditions
Conditions (2)
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 |
| Margins of Excision | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Histolog Scanner | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- All patient
- description
- All recruited patient will have their margins assessed with the confocal microscope with comparison of accuracy against gold standard histology.
- interventionNames
- Device: Histolog Scanner
Primary outcomes (1)
- measure
- To compare the sensitivity and specificity of involved margins being assessed intra-operatively using Histolog® Scanner system against conventional histology reporting for patient undergoing breast conservation surgery for breast cancer.
- timeFrame
- 6 months
- description
- To compare the sensitivity and specificity of involved margins being assessed intra-operatively using Histolog® Scanner system against conventional histology reporting for patient undergoing breast conservation surgery for breast cancer.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient capable of providing informed consent * Female * Have a diagnosis of invasive breast cancer or ductal carcinoma in-situ * Have been discussed within the multidisciplinary meeting with a recommendation that the patient is suitable for breast conservation therapy * Any localisation technique can be used of impalpable lesions (eg if the wire impairs the image quality, this will inform for full scale research) * Patient undergoing breast conservation surgery * Patient undergoing further breast conservation surgery for positive margins after previous surgery * Patient's will be able to participate for a re-excision of margin, even if they did not participate for their initial operation Exclusion Criteria: Patient undergoing mastectomy, including completion mastectomy due to involved margins * Patients undergoing excision biopsies * Male patients * Patients under the age of 18 * Unable to provide valid consent in English language
References
Publications (0)
Data not yet available
No reference posted for this study.