Marker Technique Comparison in Targeted Axillary Dissection

NCT ID: NCT05173415

Last Updated: 2025-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2025-01-31

Brief Summary

Comparison of two methods (Magnetic Marker and standard metal clip) used for localisation and extraction of lymph nodes in Targeted Axillary Dissection (TAD) in patients with breast cancer.This Project will investigate and compare the duration of intervention, detection rate and safety.

The participants will be randomized into two groups of equal size.

Detailed Description

This Project will investigate and compare the duration of intervention, detection rate and safety of two methods (Magnetic Sirius Pintuition Marker and standard metal clip) used for the localisation and extraction of lymph nodes in Targeted Axillary Dissection (TAD).

The participants will be randomized into two groups of equal size. The groups differ in terms of the method used to mark the lymph nodes prior to TAD. One group will receive a metal clip (HydroMARK© Clip), which will be localized and extracted during the tailoring surgery. Intraoperative Ultrasound is used to localize the clip. This method is considered as standard practice today.

The second group will receive Metal Clip (Sirius Pintuition) to localize axillary lymph nodes during TAD. Intraoperative localization of the lymph node will be conducted using a hand-held probe.

Successful localization of the lymph node, duration of the intervention (beginning of the localization until successful extraction) and adverse effects will be documented.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Sirius Pintution Group

Patients who are randomized for the Pintution Clip will receive a preoperative ultrasound-guided marking in the axillary lymph nodes that indicate for surgical removal. Surgical procedure is standardized with a handheld probe leading intraoperatively to the marked lymph node and its excision. Successful detection, time of the procedure (beginning of localization intervention to completed lymph node excision), and intra- and postoperative complication rate will be measured. Intra- and postoperative complications are adverse events during the surgery or within 48 hours after the surgery.

Group Type: EXPERIMENTAL

Sirius Pintution

Intervention Type: DEVICE

The intervention studies a metal Clip (Sirius Pintution) to localize axillary lymph nodes during TAD. Intraoperative localization of the lymph node will be conducted using a hand-held probe identifying the clip.

HydroMARK(C) Clip Group

Patients who are randomized for the standard clip will receive a preoperative ultrasound-guided marking with HydroMark® Clip in the axillary lymph node that indicate for surgical removal. Surgical procedure is standardized with intraoperative ultrasound-guided wire-localization of the clip and lymph node excision. Successful detection, time of the procedure (beginning of localization intervention to completed lymph node excision), and intra- and postoperative complication rate will be measured. Intra- and postoperative complications are adverse events during the surgery or within 48 hours after the surgery.

Group Type: ACTIVE_COMPARATOR

HydroMARK (C) Clip

Intervention Type: DEVICE

The control intervention is a metal clip (HydroMARK© Clip), which will be localized and extracted during the tailoring surgery. Intraoperative Ultrasound is used to localize the clip. This method is considered as standard practice today.

Interventions

Sirius Pintution

The intervention studies a metal Clip (Sirius Pintution) to localize axillary lymph nodes during TAD. Intraoperative localization of the lymph node will be conducted using a hand-held probe identifying the clip.

Intervention Type: DEVICE

HydroMARK (C) Clip

The control intervention is a metal clip (HydroMARK© Clip), which will be localized and extracted during the tailoring surgery. Intraoperative Ultrasound is used to localize the clip. This method is considered as standard practice today.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Indication: Patients undergoing lymph node marking before targeted axillary dissection due to suspicious lymph nodes or confirmed lymph node metastasis in breast cancer patients
• Female participants ≥ 18 years of age
• The subject was informed about the project and gave her written informed consent to use her data and samples for this project.
• BMI < 30
• Indication for neoadjuvant chemotherapy

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Constanze Elfgen

OTHER

Sponsor Role: lead

Responsible Party

Constanze Elfgen

Study Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Constanze Elfgen, Dr.med.

Role: PRINCIPAL_INVESTIGATOR

Brust-Zentrum AG

Locations

Brustzentrum Kantonsspital Baden

Baden, Canton of Aargau, Switzerland

Brustzentrum Bern Biel

Bern, , Switzerland

Brustzentrum Ostschweiz

Sankt Gallen, , Switzerland

Brust-Zentrum Zürich AG

Zurich, , Switzerland

Countries

Switzerland

Other Identifiers

021-013772

Identifier Type: -

Identifier Source: org_study_id