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

NANot yet recruitingINTERVENTIONAL
Enrollment

1,302

Participants

Timeline

Start Date

September 30, 2025

Primary Completion Date

September 30, 2027

Study Completion Date

December 31, 2027

Conditions
Breast CancerBreast-Conserving Surgery
Interventions
PROCEDURE

IOUS HydroMark™

"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."

PROCEDURE

Magnetic Sirius Pintuition Seed®

"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."

PROCEDURE

Wire localization (WL)

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.

Trial Locations (5)

35128

Istituto Oncologico Veneto IRCCS, Padua

Unknown

Azienda Ospedaliera San Giovanni Addolorata, Roma

Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma

AOU Policlinico di Modena, Modena

"ASL2 Abruzzo, Ospedale Gaetano Bernabeo, Ortona", Ortona

All Listed Sponsors
lead

Istituto Oncologico Veneto IRCCS

OTHER