NCT05118568

Brief Summary

Study to assess the capability of using the Histolog Scanner, a recent large field-of-view confocal laser scanning medical imaging device for the breast cancer detection in fresh lumpectomy margins.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 12, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
Last Updated

April 12, 2023

Status Verified

October 1, 2022

Enrollment Period

5 months

First QC Date

November 1, 2021

Last Update Submit

April 11, 2023

Conditions

Breast Cancer

Keywords

Breast cancerConfocal MicroscopyFresh Tissue ImagingIntraoperative AssessmentBreast Conserving Surgery

Outcome Measures

Primary Outcomes (1)

  • Accuracy, Sensitivity, Specificity for breast cancer detection

    Quantification of the performance achieved by breast surgeons and pathologists for breast cancer detection in Histolog Scanner images of lumpectomy margins

    Through study completion, an average of 6 months

Secondary Outcomes (1)

  • Theoretical impact on re-operation rates

    Through study completion, an average of 6 months

Interventions

Histolog ScannerDEVICE

imaging of fresh lumpectomy specimens with the Histolog Scanner, confocal microscopy scanning medical imaging device

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patient are selected by breast surgeons during their standard-of-care preoperative consultations

You may qualify if:

  • Adult female patient ≥18 years old
  • Patient Scheduled for breast conserving surgery of invasive and/ or in situ ductal carcinoma (DCIS).
  • Patient able to read, understand and give informed consent

You may not qualify if:

  • Patient previously treated for ipsilateral breast cancer surgery
  • Patient with previous radiotherapy of the breast
  • Patient with multicentric breast cancer
  • Patients with planed mastectomy, tumor-adapted breast reduction
  • Patient with presurgical neo-adjuvant treatment
  • Patient is pregnant/lactating
  • Participation in any other clinical study that would affect data acquisition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Vincenz-Krankenhaus GmbH, Frauenklinik St. Louise

Paderborn, Germany

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Michael P Lux, MD, MBA

    St. Vincenz-Krankenhaus GmbH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2021

First Posted

November 12, 2021

Study Start

October 1, 2020

Primary Completion

February 15, 2021

Study Completion

May 31, 2022

Last Updated

April 12, 2023

Record last verified: 2022-10

Locations

DE(1)