Marker Technique Comparison in Targeted Axillary Dissection

NCT05173415 | Completed

• 1 other identifier: 021-013772
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 4

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• To compare clinical manageability, efficacy, safety, and sufficiency of two lymph node marking systems (HydroMark Clip versus Sirius Pintuition)

  The primary outcome is the efficacy of both methods for lymph node marking. Efficacy is defined as performance time during the surgery from skin incision (either with hooked wire or scalpel) until the complete excision of the marked lymph node. Time is measured in minutes. Manageability includes process performance of the marker insertion (questionnaire for the study physician: "did you experience problems or barriers in inserting the marker?"; "if yes, what kind of?"). Safety is also observed via the questionnaire ("did your patient experience adverse events? bleeding, seroma, (...), other?"). This is also true for sufficiency ("Did you acieve a successful lymph node marking?"; "Have you been able to localize the marker during the surgery or has it been dislocated?"; "Did you manage to remove the marked lymph node including the marker").

  6 months

Secondary Outcomes (4)

• Failure rate (unsuccessful localisation of the marked lymph node)

  6 months

• Incidence of complications of both methods used for lymph node marking.

  6 months

• Adverse events

  6 months

• Satisfaction of the performing Surgeon concerning the handling of the marking technique documented in the Case Report Form.

  6 months

Other Outcomes (1)

• Incidence of intraoperative complications and postoperative adverse events.

  6 months

Study Arms (2)

Sirius Pintution Group

EXPERIMENTAL

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.

Device: Sirius Pintution

HydroMARK(C) Clip Group

ACTIVE COMPARATOR

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.

Device: HydroMARK (C) Clip

Interventions

Sirius Pintution 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.

Sirius Pintution Group

HydroMARK (C) Clip 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.

HydroMARK(C) Clip Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Constanze Elfgen: lead

Study Sites (4)

Brustzentrum Kantonsspital Baden

Baden, Canton of Aargau, 5404, Switzerland

Location

Brustzentrum Bern Biel

Bern, 3031, Switzerland

Location

Brustzentrum Ostschweiz

Sankt Gallen, 9016, Switzerland

Location

Brust-Zentrum Zürich AG

Zurich, 8008, Switzerland

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Surgical Instruments

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Surgical Equipment; Equipment and Supplies

Study Officials

• Constanze Elfgen, Dr.med.

  Brust-Zentrum AG

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Study Principal Investigator

Model Details: A prospective, randomized multi-centre trial

Study Record Dates

• First Submitted: October 28, 2021
• First Posted: December 30, 2021
• Study Start: August 1, 2023
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: February 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (4)