Safety & Performance of CANOpus PINtuition Surgical Marker Navigation (CANOPIN)

Safety & Performance of CANOpus PINtuition Surgical Marker Navigation (CANOPIN)

The goal of this clinical trial is to evaluate the safety and performance of the Canopus Marker in adult breast cancer patients who are scheduled for breast-conserving surgery. The main questions it aims to answer are:

1. Can the Canopus Marker be safely and effectively used to mark tissue for surgical removal?
2. What is the satisfaction level of radiologists, surgeons, and patients with the use of the Canopus Marker?

Participants will:

• Have the Canopus Marker implanted into the tumor or nearby tissue using ultrasound guidance.
• Undergo surgery where the Canopus Marker will help guide the surgeon to the tumor, and the marker will be removed along with the tumor. This surgery is performed using an FDA cleared and CE-marked detection device (Sirius Pintuition Detector).
• Attend a follow-up visit two weeks after surgery to assess any adverse events and overall satisfaction.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Surgery; Lymph Node Excision
• Intervention / Treatment: Device: Magnetic seed

Detailed Description

Breast cancer remains one of the most prevalent malignancies affecting women worldwide, necessitating a range of treatment modalities to manage and combat the disease effectively. These modalities include surgery, radiation therapy, chemotherapy, hormone therapy, and targeted therapy. Among these, breast-conserving surgery (BCS), also known as lumpectomy, has become a cornerstone of breast cancer treatment. BCS involves the removal of the cancerous tissue while preserving as much of the breast as possible. This approach aims to achieve oncologic safety comparable to mastectomy while offering psychological and cosmetic benefits. The success of BCS has been augmented by advancements in imaging techniques and surgical tools, facilitating precise tumour localization and excision.

Over the years, various localization technologies have been developed to enhance the precision of breast cancer surgeries. Traditional methods like wire localization have been widely used but are often associated with discomfort and logistical challenges. Advances in medical technology have led to non-wire localization methods such as radioactive seed localization (RSL) and radar systems. The commercially available Sirius Pintuition system, using magnetic seed localization, involves inserting a small magnetic marker into the tumour site, detectable with a magnetic probe during surgery. This system aims to offer advantages like improved subject comfort, precise localization, and ease of use for surgeons. The investigational Canopus Marker, building on Sirius Pintuition's success, aims to further improve the precision and effectiveness of breast-conserving surgeries. The Canopus Marker incorporates additional anchoring mechanisms designed to enhance its stability during breast-conserving surgeries. These enhancements aim to mitigate any potential risk of dislodgement, while maintaining the marker's detectability and ease of use for surgeons.

The present investigation is only evaluating if the additional anchors added to the Pintuition Marker, which is the Canopus Marker, is also safe and performing as intended. Therefore, the present investigation will be similar in design as the study that was conducted to obtain the Pintuition System's CE mark. That is, a single-arm, open-label study in one centre in The Netherlands. The sample size (n=35) is determined to demonstrate that the Canopus Marker does not perform worse than the Pintuition Marker and other similar marker-based localization devices.

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bram Schermers, CEO/CTO; Phone Number: +31 6 48044508; Email: bram.schermers@sirius-medical.com
• Study Contact Backup: Name: Kitty Kempen Kempen, PhD, Clinical Affairs Director; Phone Number: +31 6 10223238; Email: kitty.kempen@sirius-medical.com

Study Locations

• Netherlands
  • Noord-Holland
    • Beverwijk, Noord-Holland, Netherlands, 1942 LE
      • Rode Kruis Ziekenhuis
      • Contact: Carlinda Bresser, Research Coordinator
      • Contact: Niels Harlaar, Surgeon
      • Contact: Gisela Moormann, Surgeon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Subject is willing and able to provide informed consent for the investigation
2. Subject is at least 18 years of age
3. Subject is diagnosed with a single, pathologically confirmed unifocal breast tumour (DCIS or invasive)
4. Tumour is ultrasound visible
5. Subject is indicated for primary breast conserving surgery and/or targeted axillary dissection
6. Subject is indicated for preoperative localization using a single marker in the primary breast lesion and/or a single marker in an axillary lymph node

Exclusion Criteria:

1. Subject is lactating or pregnant
2. Subject is expected to have surgery scheduled more than 6 weeks after implantation of the Canopus Marker.
3. Subject has an ICD or other active implant such as a pacemaker less than 5 cm away from the intended target location(s)
4. Subject has a proven infection or clinically significant hematoma at or close to the intended target location(s)
5. Subject is expected to require an MRI scan in the period between implantation and surgery
6. Known hypersensitivity to Titanium or Nickel

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Primary breast lesion and/or axillary lymph node localisation prior to surgical excision; Device: CANOPUS Magnetic Marker by Sirius Medical Systems B.V. Placement of experimental device in primary breast lesion and/or axillary lymph node indicated for surgical removal and requiring localisation	Device: Magnetic seed; All patients enrolled will receive a single Sirius Canopus Marker with two anchors added to it for improved tissue fixation. Implantation will be done by a radiologist before breast conserving surgery, usually scheduled within a few days after Canopus Marker implantation. The Canopus Marker is removed with the specimen during the surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance: Retrieval Rate	Proportion of procedures in which the Canopus marker is present on post-operative specimen X-ray and only the Pintuition Detector is used during surgery. Hypothesis: => 85%	From enrolment to the follow-up visit at 2 weeks after surgery (estimated 3-5 weeks)
Safety: Investigational Device-Related Serious Adverse Device Effects	Proportion of patients who experienced an investigational device-related serious adverse device effect as assessed by MedDRA. Hypothesis: none.	From enrolment to the follow-up visit at 2 weeks after surgery (estimated 3-5 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiologist's Satisfaction	The secondary performance endpoints and hypotheses of this clinical investigation include: an overall radiologist satisfaction score of ≥7 measured on a 10-point Likert scale or comparable index	Post-procedural (implantation)
Surgeon Satisfaction	The secondary performance endpoints and hypotheses of this clinical investigation include: an overall surgical satisfaction score of ≥7 measured on a 10-point Likert scale or comparable index	Post-procedural (surgery)
Subject Satisfaction	The secondary performance endpoints and hypotheses of this clinical investigation include: an overall subject satisfaction score of ≥7 measured on a 10-point Likert scale or comparable index	At post-operative check (2 weeks follow-up visit)
Safety: Adverse Events	Secondary safety endpoints include the reporting of the incidence, severity and causal relationship of adverse events (AEs), adverse device effects (ADEs), serious adverse events (SAEs), unanticipated serious adverse device events (USADEs) and device deficiencies (DDs) in accordance with ISO 14155:2020 definitions	From enrolment to the follow-up visit at 2 weeks after surgery (estimated 3-5 weeks)
Accuracy of Placement	Average distance between Canopus Marker centre and tumour centre on the two post-placement mammographic images in mm	Post-procedural (implantation)
Operative Time	Minutes from first incision until wound closure	Post-procedural (surgery)
Transcutaneous Detection Succesful	Proportion of procedures in which a reliable signal of the Canopus Marker is detected on the intact skin using the Pintuition Detector	Periprocedural (surgery)
Marker Dislodgements	Proportion of procedures in which the Marker dislodged during the surgical procedure.	Post-procedural (surgery)
Reoperation Rate	Second, separate surgical procedure of same lesion or area indicated after multidisciplinary discussion	From enrolment to the follow-up visit at 2 weeks after surgery (estimated 3-5 weeks)

Collaborators and Investigators

• Sponsor: Sirius Medical Systems B.V.
• Collaborators: Avania B.V.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2025
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: April 15, 2025
• First Submitted That Met QC Criteria: April 22, 2025
• First Posted (Actual): April 29, 2025

Study Record Updates

• Last Update Posted (Actual): April 29, 2025
• Last Update Submitted That Met QC Criteria: April 22, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: surgical navigation; Breast conserving surgery; magnetic seed localization; pintuition; breast sparing surgery; surgical localization
• Other Study ID Numbers: CANOPIN; NL-MF-000010932 (Other Identifier: CCMO)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No