Breast CancerIMTADNCT04580251
Ideal Marker for Targeted Axillary Dissection
An observational study of Breast Cancer, run by University Hospital Ostrava at 5 sites in Czechia.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Targeted axillary dissection
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 5 sitesCzechia
- Study dates
- 1 Jan 2021to 30 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with breast cancer confirmed with a biopsy, indicated for neoadjuvant chemotherapy and axillary dissection, in whom pathological lymph nodes have been marked using one of the three examined and compared markers.
Who may be able to join
- 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)
Who cannot join
- refusal to participate in the study
- another treatment protocol, which does not include targeted axillary dissection
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Czechia5 sites
Masaryk Memorial Cancer Institute
Brno, South Moravian, 65653
Silesian Hospital in Opava
Opava, Moravian-Silesian Region, 74601
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, 70852
Institute for the Care of Mother and Child, Prague, Czech Republic
Prague, Prague, 14700
EUC Clinic in Zlín
Zlín, Zlín, 76001
About this study
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.
Read the detailed description
There are two basic aims of the study
- Prospective comparison of the reliability and accuracy of individual markers used for marking of a pathological axillary lymph node with subsequent targeted axillary dissection.
- 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)
- Conditions
- Breast Cancer
- Being tested
- Targeted axillary dissection
- Keywords
- breast cancer, axillary dissection, Magseed marker, iodine seed, carbon suspension, axillary lymph node
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted axillary dissectionProcedure or surgery
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)
| Study group | Role | What they receive |
|---|---|---|
| Magnetic marker Magseed | Patients in whom the magnetic marker Magseed is used will be enrolled in this study arm and will undergo targeted axillary dissection. Receives: Procedure: Targeted axillary dissection | |
| Iodine seed 125I marker | Patients in whom the iodine seed 125I marker is used will be enrolled in this study arm and will undergo targeted axillary dissection. Receives: Procedure: Targeted axillary dissection | |
| Carbon suspension | Patients in whom the carbon suspension marker is used will be enrolled in this study arm and will undergo targeted axillary dissection. Receives: Procedure: Targeted axillary dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depth of marker implantation
The depth of marker implantation will be assessed and measured in millimetres
Measured: During surgery/intervention
Marker migration
Marker migration will be assessed and measured in millimetres
Measured: During surgery/intervention
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.
Measured: 1 month
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
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start1 Jan 2021
- Primary completion1 Jan 2023
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Collaborators
- Silesian Hospital in Opava, Masaryk Memorial Cancer Institute, EUC Clinic in Zlín, Institute for the Care of Mother and Child, Prague, Czech Republic, University of Ostrava
- Responsible party
- Sponsor
- Investigators
- Jan Žatecký, MD, Principal investigator, Silesian Hospital in Opava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04580251
- Sponsor's protocol ID
- CHIR-05-IMTAD
- Acronym
- IMTAD
- Status last verified
- Sep 2023
- First submitted
- 1 Oct 2020
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data may be made available to other researchers upon request.
Publications
Zatecky J, Coufal O, Zapletal O, Kubala O, Kepicova M, Faridova A, Raus K, Gatek J, Kosac P, Peteja M. Ideal marker for targeted axillary dissection (IMTAD): a prospective multicentre trial. World J Surg Oncol. 2023 Aug 19;21(1):252. doi: 10.1186/s12957-023-03147-x.
PubMed 37596658
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ideal Marker for Targeted Axillary Dissection
- ClinicalTrials.gov ID
- NCT04580251
- Acronym / sponsor ID
- IMTAD / CHIR-05-IMTAD
- Conditions
- Breast Cancer
- Keywords
- breast cancer, axillary dissection, Magseed marker, iodine seed, carbon suspension, axillary lymph node
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Collaborators
- Silesian Hospital in Opava, Masaryk Memorial Cancer Institute, EUC Clinic in Zlín, Institute for the Care of Mother and Child, Prague, Czech Republic, University of Ostrava
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 8 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
There are two basic aims of the study
- Prospective comparison of the reliability and accuracy of individual markers used for marking of a pathological axillary lymph node with subsequent targeted axillary dissection.
- 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)
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Magnetic marker Magseed | – | Procedure: Targeted axillary dissectionPatients in whom the magnetic marker Magseed is used will be enrolled in this study arm and will undergo targeted axillary dissection. |
| Iodine seed 125I marker | – | Procedure: Targeted axillary dissectionPatients in whom the iodine seed 125I marker is used will be enrolled in this study arm and will undergo targeted axillary dissection. |
| Carbon suspension | – | Procedure: Targeted axillary dissectionPatients in whom the carbon suspension marker is used will be enrolled in this study arm and will undergo targeted axillary dissection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with breast cancer confirmed with a biopsy, indicated for neoadjuvant chemotherapy and axillary dissection, in whom pathological lymph nodes have been marked using one of the three examined and compared markers.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (2 listed)
- refusal to participate in the study
- another treatment protocol, which does not include targeted axillary dissection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Targeted axillary dissectionThe 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) | Procedure or surgery | Carbon suspension, Iodine seed 125I marker, Magnetic marker Magseed |
Primary outcome
Depth of marker implantation
Time frame: During surgery/intervention
The depth of marker implantation will be assessed and measured in millimetres
Marker migration
Time frame: During surgery/intervention
Marker migration will be assessed and measured in millimetres
Success-rate of resection of the marked lymph node
Time frame: 1 month
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
Time frame: 1 month
The time from localizing the pathological lymph node using the marker to surgery will be analysed and measured in days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Derived from this study: PubMed 37596658Zatecky J, Coufal O, Zapletal O, Kubala O, Kepicova M, Faridova A, Raus K, Gatek J, Kosac P, Peteja M. Ideal marker for targeted axillary dissection (IMTAD): a prospective multicentre trial. World J Surg Oncol. 2023 Aug 19;21(1):252. doi: 10.1186/s12957-023-03147-x.
- Individual participant dataSharing planned: No. Individual participant data may be made available to other researchers upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Žatecký, MD principal investigator
Silesian Hospital in Opava
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by University Hospital Ostrava at 5 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depth of marker implantation (time frame: During surgery/intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04580251, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2023.