Clinical trial NCT05118568: Assessment of Lumpectomy Margins With the Histolog Scanner in Comparison With Intraoperative Imaging Techniques
Official title: Imaging of Lumpectomy Surface With Large Field-of-View Confocal Laser Scanning Microscope 'Histolog Scanner' for Breast Margin Assessment in Comparison With Intraoperative Imaging and Postoperative Histopathological Assessment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Breast cancer
Confocal Microscopy
Fresh Tissue Imaging
Intraoperative Assessment
Breast Conserving Surgery
Lead sponsor: SamanTree Medical SA
Sponsor class: INDUSTRY
Collaborators: name: St. Vincenz Krankenhaus GmbH, Paderborn
First posted: 2021-11-12
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient are selected by breast surgeons during their standard-of-care preoperative consultations

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.

Detailed description: Breast cancer is the most common cancer in women. For early-stage breast cancers, breast-conserving surgery (BCS) is applied to excise the tumor while saving surrounding healthy tissue as much as possible to avoid radical excisions and achieve better aesthetic and psychological outcomes for the patient. This surgical approach requires postoperative tumor-free margin assessment of the surgical resection in order to carry on with next steps of the patient care treatment (e.g. radiotherapy). Unfortunately, at least 20% of patient undergo more than one procedure to achieve acceptable margin status due to difficulties to identify subclinical and deep-seated tumor during BCS. During the surgery, the surgeon mainly relies on nonspecific visual changes and manual palpation of subtle irregularities to guide cancer excision. While these determinants enable bulk tumor assessment, they do not offer the information to adequately identify tumor infiltrates on lumpectomy margin.

An efficient intraoperative assessment of the margin may solve these issues and confocal imaging has shown some promises by providing real-time imaging of fresh tissue with the resolution sufficient to visualize microscopic tissue features. The Histolog Scanner is a recent confocal microscope designed for clinical use on large surgical specimens.

The main objective of this study is to confirm that the use of the Histolog Scanner by surgeons allows to detect breast cancer on lumpectomy margins and compare the performance of the detection with local standard-of-care intraoperative imaging techniques (ultrasound and radiography) using the final assessment performed in pathology as reference.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Accuracy, Sensitivity, Specificity for breast cancer detection
timeFrame: Through study completion, an average of 6 months
Secondary outcomes:
measure: Theoretical impact on re-operation rates
timeFrame: Through study completion, an average of 6 months
Other outcomes:
Locations:
city: Paderborn
country: Germany
facility: St. Vincenz-Krankenhaus GmbH, Frauenklinik St. Louise
Study officials:
affiliation: St. Vincenz-Krankenhaus GmbH
name: Michael P Lux, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References: