Ideal Marker for Targeted Axillary Dissection

Breast Cancer Clinical Trial

— IMTAD  

Official title:

Ideal Marker for Targeted Axillary Dissection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04580251
• Other study ID #: CHIR-05-IMTAD
• Status: Completed
• Start date: January 1, 2021
• Est. completion date: May 30, 2023

Study information

• Verified date: September 2023
• Source: University Hospital Ostrava
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A multicentre prospective comparative study, comparing the use of various markers (magnetic marker Magseed, iodine seed 125I, carbon suspension) for marking a pathological lymph node in patients with breast carcinoma prior to neoadjuvant therapy and subsequent surgical treatment consisting of targeted axillary dissection.

Description:

There are two basic aims of the study

1. Prospective comparison of the reliability and accuracy of individual markers used for marking of a pathological axillary lymph node with subsequent targeted axillary dissection.

2. Comparison of the number of complications during localizing and detection of individual markers and postoperative complications.

In individual collaborating centers, these markers are commonly used in clinical practice for marking of a pathological lymph node in patients with breast carcinoma. The usual standard of practice and treatment will not be changed in any way; the patients will only be prospectively followed. The study will bring an answer to the question of which marker is the best for marking lymph nodes.

Apart from the basic demographic and other data (patient age, side of the body, size and characteristics of the tumor (typing, grading, staging), type and time of surgery, the incidence of complications during implantation or detection of the marker, number of lymph nodes, complications after surgery, and the final histological findings, also the following outcome measures will be observed:

• depth of marker implantation (measured in mm)

• marker migration (measured in mm)

• success-rate of resection of the marked lymph node - assessment, whether the lymph node was removed (yes/no) using the respective marker, expressed in percent of successful removal for the respective marker

• time from localizing the pathological lymph node using the marker to surgery (measured n days)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 30, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• diagnosis of breast cancer, confirmed with a biopsy

• indication of neoadjuvant therapy

• biopsy of pathologically enlarged axillary lymph node and marking of the lymph node using one of the markers before neoadjuvant chemotherapy

• surgical treatment after neoadjuvant chemotherapy (targeted axillary dissection)

Exclusion Criteria:

• refusal to participate in the study

• another treatment protocol, which does not include targeted axillary dissection

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• Targeted axillary dissection
The surgical treatment procedure of targeted axillary dissection performed in patients in whom the pathological lymph nodes have been marked using the examined and compared markers (magnetic marker Magseed, iodine seed 125I, carbon suspension)

Locations

Country	Name	City	State
Czechia	Masaryk Memorial Cancer Institute	Brno	South Moravian Region
Czechia	Silesian Hospital in Opava	Opava	Moravian-Silesian Region
Czechia	University Hospital Ostrava	Ostrava	Moravian-Silesian Region
Czechia	Institute for the Care of Mother and Child, Prague, Czech Republic	Praha	Prague
Czechia	EUC Clinic in Zlín	Zlín	Zlín Region

Sponsors (6)

Lead Sponsor	Collaborator
University Hospital Ostrava	EUC Clinic in Zlín, Institute for the Care of Mother and Child, Prague, Czech Republic, Masaryk Memorial Cancer Institute, Silesian Hospital in Opava, University of Ostrava

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depth of marker implantation	The depth of marker implantation will be assessed and measured in millimetres	During surgery/intervention
Primary	Marker migration	Marker migration will be assessed and measured in millimetres	During surgery/intervention
Primary	Success-rate of resection of the marked lymph node	Assessment, whether the lymph node was removed (yes/no) using the respective marker, expressed in percent of successful removal for the respective marker.	1 month
Primary	Time from localizing the pathological lymph node using the marker to surgery	The time from localizing the pathological lymph node using the marker to surgery will be analysed and measured in days	1 month