CairnSurgical Breast Cancer Locator (BCL) Post-Market Study

Last updated: June 11, 2024
Sponsor: CairnSurgical, Inc.
Overall Status: Completed

Phase

N/A

Condition

Cancer

Breast Cancer

Treatment

Breast Cancer Locator Guided Breast Conserving Surgery

Clinical Study ID

NCT06461663
CS-BCL-EU2021
  • Ages > 18
  • Female

Study Summary

This interventional, post-market, multicenter clinical investigation is designed to evaluate the performance of a custom-made medical device, "the Breast Cancer Locator (BCL)" in Subjects with non-palpable breast cancer, in Europe.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient Informed consent form (ICF) signed

  • Female Aged ≥ 18 years at the time of the signature of ICF

  • Histologic diagnosis of IBC or DCIS

  • Tumor excision that will require localization because it cannot be definitivelydefined by palpation

  • The tumor is unifocal; possible satellite lesions < 2 cm from primary are eligible

  • The tumor enhances and is greater than or equal to 5mm on prone breast MRI imaging

  • Subject and surgeon agree to perform BCS

  • Willingness to follow all study procedures, including attending all site visits,tests and examinations.

Exclusion

Exclusion Criteria:

  • Absolute contraindication to MRI, including presence of implanted electrical device (e.g., pacemaker or neurostimulator), aneurysm clip, or metallic foreign body in ornear eyes

  • Severe claustrophobia

  • Contraindication to use of gadolinium-based intravenous contrast, includinglife-threatening allergy

  • Uncontrolled cardiac, renal, or pulmonary disease

  • Uncontrolled systemic disease (e.g., lupus erythematosus or scleroderma)

  • Compromised renal function including chronic, severe kidney disease (GFR < 30ml/min/1.73m2), or acute kidney injury

  • Pregnancy or breast-feeding

  • Subjects who have received or plan to receive neoadjuvant chemotherapy

  • Sternal notch to nipple distance of > 32 cm as measured in a sitting or standingposition

  • Measurement of widest circumference around breasts and arms > 135 cm

  • Known allergy to device components

  • Multicentric tumors (additional tumors > 2 cm from primary)

  • Infectious or inflammatory processes near the area of intervention

  • Planned surgery with localization devices including WGL, intraoperative ultrasoundguidance, radiofrequency emitting implants, magnetic seeds, radioactive seeds, andtissue inspection devices

  • Simultaneous participation in an interventional study or participation in aninterventional study in the last 1 month before study inclusion

  • Known drug and/or alcohol abuse

  • Mental incapacity that precludes adequate understanding or cooperation

Study Design

Total Participants: 35
Treatment Group(s): 1
Primary Treatment: Breast Cancer Locator Guided Breast Conserving Surgery
Phase:
Study Start date:
July 22, 2022
Estimated Completion Date:
April 19, 2024

Study Description

The aim of this interventional, post-market, multicenter clinical investigation is to evaluate the performance of a custom-made medical device, the Breast Cancer Locator (BCL) system, in subjects with non-palpable breast cancer. The study will be conducted in European countries. To evaluate the performance of BCL in reducing the positive margin rate, the proportion of patients with positive margins after partial mastectomy with the BCL will be obtained.

Each Subject, after signing an Informed Consent Form (ICF), will enter into a screening phase, during which several assessments (e.g., demographics, medical history, evaluation of available prone MRI and core biopsy pathological results) will be conducted.

At visit 1, the Subject will undergo supine MRI, from which a 3D breast image and BCL will be made.

At visit 2, the patient will undergo Breast Conserving Surgery (BCS) using the BCL system. On the same day, the specimen volume will be determined. The excised specimen will be sent to the pathological lab for analysis. The results, including the positive margin rate (PMR) and specimen mammogram, will be obtained within 14 days.

At visit 3, follow-up assessments (including physical examination, and adverse event review) will be performed.

At the End Of Study visit, adverse events will be assessed and patients will be asked to express their satisfaction with the BREAST-Q.

Connect with a study center

  • Agaplesion Markus Hospital

    Frankfurt, 60431
    Germany

    Site Not Available

  • Universitats Klinikum Heidelberg

    Heidelberg,
    Germany

    Site Not Available

  • Humanitas Research Hospital

    Milan,
    Italy

    Site Not Available

  • Ospdale Santa Chiara

    Pisa,
    Italy

    Site Not Available

  • Spital Zollikerberg

    Zürich,
    Switzerland

    Site Not Available

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