IntraOperative UltraSound Guided vs Wire Guided vs Magnetic Seed Guided Breast-Conserving Surgery for Non-palpable Tumors

Sponsor
Istituto Oncologico Veneto IRCCS
Study ID
NCT07185568
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • IOUS HydroMark™ — PROCEDURE
    IOUS HydroMarkTM allows marking the tissue during percutaneous breast biopsy. This is a sterile, single-use marker made of resorbable hydrogel, which expands upon contact with bodily fluids and is then gradually absorbed. The hydrogel is visible on ultrasound. Inside the hydrogel, there is a metallic spiral (titanium/steel) that remains permanently visible in radiographic and MRI examinations even after the hydrogel has been fully absorbed. The HydroMARK Breast Biopsy Site Marker is made of a resorbable hydrogel that expands with fluid and is then resorbed. The hydrogel material is visible under ultrasound. Embedded in the hydrogel is a coiled metallic wire that will be permanently visible under x-ray and MRI when the hydrogel is resorbed. The HydroMARK Biopsy Site Marker is a permanent implant and is not intended to be removed unless the marked tissue is determined to require surgical removal. The marker is supplied pre-loaded in applicator devices designed.
  • Magnetic Sirius Pintuition Seed® — PROCEDURE
    The Pintuition Localization System is intended as a magnetic soft tissue localization system. The magnetic Pintuition Seed is indicated for preoperative percutaneous implantation into soft tissue (glandular, fibrous or fatty tissue of breast; lymph nodes in the axillary and inguinal region; subcutaneous tissue and skeletal muscle tissue) for temporary marking (\<180 days) of a tissue of interest (e.g. tumor or a suspected lesion) indicated for surgical removal. Using the Pintuition Detector as magnetic guidance or, alternatively, image guidance (ultrasound or x-ray), the Pintuition Seed can be intra-operatively localized and removed together with the tissue of interest.
  • Wire localization (WL) — PROCEDURE
    Single-use, repositionable needle for preoperative localization of breast nodules with a single hook, equipped with a depth limiter. Designed for the localization of non-palpable breast lesions in the preoperative phase. It includes a fixation clamp to stabilize the positioning of the wire.

Study Details

This is a multi-center, randomized, open-label clinical trial that will enroll 1302 adult patients with non-palpable breast lesions. Participant eligible for the study will be randomized in a 1:1:1 ratio to one of the pre-surgery lesion localization: IOUS HydroMark™ (experimental arm A), magnetic Sirius Pintuition Seed® (experimental arm B) and the wire localization technique (control arm). The randomization will be stratified by lesion type (solid non-palpable (type B); non-solid non-palpable (e.g., microcalcification clusters, architectural distortive areas) (type C); post-NACT residual lesions (type D), and clinical center.

Key Dates

First listed
Sep 22, 2025
Start date
Aug 4, 2026
Status verified
Jun 2026
Primary completion
Sep 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
1,302 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: IntraOperative Ultrasound (IOUS) HydroMark™
    It is an advanced localization technique for non-palpable breast lesions, leveraging real-time ultrasound guidance combined with an ultrasound-visible tissue marker (HydroMark™) to facilitate precise tumor resection during breast-conserving surgery (BCS).
  • Experimental: Magnetic Sirius Pintuition Seed®
    It is an advanced, wire-free localization system designed for precise surgical guidance in non-palpable breast lesions. This technology utilizes a small, permanent magnetic seed that can be implanted into the tumor days, weeks, or even months before surgery, offering greater flexibility compared to traditional wire localization.
  • Active Comparator: Wire localization
    It is the most widely used preoperative technique for guiding the surgical removal of non-palpable breast lesions. This method involves the insertion of a thin hooked wire into the lesion under radiological guidance (ultrasound, mammography, or stereotactic guidance) on the day of surgery. The wire serves as a physical guide for the surgeon, ensuring precise excision of the target lesion.

Primary Outcome Measure

Involved resection margins. [ Time Frame: Through study completion, an average of 2 years ]

Central Contacts

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