Breast CancerMagTraceNCT05122585
Magnetic Tracer in the Sentinel Node Procedure in Breast Cancer: the Non-radioactive Alternative for Radio-isotopes
A study testing MagSeed and MagTrace in breast cancer patiënts in people with Breast Cancer, run by Zuyderland Medisch Centrum at 1 site in Netherlands.
Trial summary
Rationale: In breast cancer, a sentinel node procedure is performed to investigate whether malignant cells have spread to the axillary lymph nodes. This is an important part of determining the stage of breast cancer and the final treatment plan. 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?
- MagSeed and MagTrace in breast cancer patiënts
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Aug 2021to 9 Feb 2022
- Phase
- Interventional
- 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
Who may be able to join
- Female patient of 18 years or older.
- Patient with breast cancer and indication for sentinel node procedure.
Who cannot join
- Patients with a previous history of the sentinel node procedure or axillary lymph node dissection in the unilateral breast.
- Unable to comprehend implications and extent of study and sign for informed consent.
- Known allergy or hypersensitivity to iron oxide or dextran.
Trial locations and contacts
1 site in 1 country.
About this study
Rationale:
In breast cancer, a sentinel node procedure is performed to investigate whether malignant cells have spread to the axillary lymph nodes. This is an important part of determining the stage of breast cancer and the final treatment plan.
Read more
A disadvantage of the sentinel node procedure is that it is performed using radioactive tracing with concomitant radiation exposure for the patients and involved health care personnel. In addition, the use of radioactive tracing puts high demands on the logistics in the operation theatre: the capacity of patients that can be treated in one day is limited and the radio-active tracing leads to many time-consuming precautionary measures.
A radiation free alternative would therefore have multiple advantages. Not only with respect to radiation exposure for the patients and health care workers, but also by reducing the waiting time for operation for the patients as it will make the planning of patients for surgery more efficient.
Recently, a radiation free tracer for the sentinel node procedure has become available (Magtrace). This tracer has been tested in small-case studies and is currently used as standard care in several hospitals around the world.
Objective:
The primary objective of this study is to evaluate the diagnostic accuracy of Magtrace in the sentinel node procedure in breast cancer in the Breast Care Centre in Zuyderland Medical Centre; with the ultimate goal to make the sentinel node procedure a radiation free process.
Study design:
A prospective cohort of forty patients with breast cancer and an indication for a sentinel node procedure will be injected with both Technetium (radioisotope) and Magtrace (magnetic). All patients in this study will receive both tracers.
Study population:
Patients of 18 years or older with breast cancer and an indication for a sentinel node procedure will be included. These patients will be recruited by their breast surgeon in the outpatient department of the Breast Care Centre in Zuyderland Medical Centre.
Intervention (if applicable):
Sentinel node procedure using a magnetic tracer next to Technetium.
Main study parameters/endpoints:
The concordance in detection of sentinel nodes by Magtrace and the Technetium tracer, measured by the sensitivity and specificity of Magtrace in detecting sentinel nodes with Technetium tracer as gold standard.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
The goal of this project is evaluating the diagnostic accuracy of Magtrace in the sentinel node procedure. To establish that Magtrace is a non-inferior and a non-radioactive alternative for Technetium with respect to reliability in detecting metastases. The ultimate goal is to make the sentinel node procedure a radiation free process.
- Conditions
- Breast Cancer
- Being tested
- MagSeed and MagTrace in breast cancer patiënts
- Keywords
- MagTracer, Sentinel Lymph Node, Breast Cancer, MagSeed, Magnetic Tracer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MagSeed and MagTrace in breast cancer patiëntsProcedure or surgery
Combining MagSeed and Magtracer to perform a wide local excision breast conserving surgery and sentinel node biopsy.
| Study group | Role | What they receive |
|---|---|---|
| Prospective MagTrace patients | Experimental | All prospective patients will receive a MagSeed in the diagnosed breast cancer tumor. In addition, they will receive MagTrace to detect the sentinel lymph node during surgery. Since this is an experimental study, the patients will also be injected with the golden standard of Technetium tracer. Receives: Procedure: MagSeed and MagTrace in breast cancer patiënts |
What is being measured
The primary outcome is the main question the study is designed to answer.
The concordance in detection of sentinel nodes by Magtrace and the Technetium tracer.
Number of sentinel lymph nodes detected using MagTrace and Technetium and their concordance.
Measured: During surgery
Secondary outcomes (1)
Operation time sentinel node procedure
Surgery time.
Measured: During Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2021
- Study start1 Aug 2021
- Primary completion9 Feb 2022
- Study completion9 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zuyderland Medisch Centrum
- Sponsor type
- University, hospital or other
- Collaborators
- Sysmex America, Inc.
- Responsible party
- Principal investigator, Yvonne Vissers, Zuyderland Medisch Centrum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05122585
- Sponsor's protocol ID
- METCZ20200211
- Acronym
- MagTrace
- Status last verified
- Mar 2022
- First submitted
- 4 Nov 2021
- Last updated
- 1 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Tracer in the Sentinel Node Procedure in Breast Cancer: the Non-radioactive Alternative for Radio-isotopes
- ClinicalTrials.gov ID
- NCT05122585
- Acronym / sponsor ID
- MagTrace / METCZ20200211
- Conditions
- Breast Cancer
- Keywords
- MagTracer, Sentinel Lymph Node, Breast Cancer, MagSeed, Magnetic Tracer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Zuyderland Medisch CentrumUniversity, hospital or other
- Collaborators
- Sysmex America, Inc.
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 9 Feb 2022 (actual)
- Study completion
- 9 Feb 2022 (actual)
- First posted
- 17 Nov 2021 (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.
Rationale:
In breast cancer, a sentinel node procedure is performed to investigate whether malignant cells have spread to the axillary lymph nodes. This is an important part of determining the stage of breast cancer and the final treatment plan.
A disadvantage of the sentinel node procedure is that it is performed using radioactive tracing with concomitant radiation exposure for the patients and involved health care personnel. In addition, the use of radioactive tracing puts high demands on the logistics in the operation theatre: the capacity of patients that can be treated in one day is limited and the radio-active tracing leads to many time-consuming precautionary measures.
A radiation free alternative would therefore have multiple advantages. Not only with respect to radiation exposure for the patients and health care workers, but also by reducing the waiting time for operation for the patients as it will make the planning of patients for surgery more efficient.
Recently, a radiation free tracer for the sentinel node procedure has become available (Magtrace). This tracer has been tested in small-case studies and is currently used as standard care in several hospitals around the world.
Objective:
The primary objective of this study is to evaluate the diagnostic accuracy of Magtrace in the sentinel node procedure in breast cancer in the Breast Care Centre in Zuyderland Medical Centre; with the ultimate goal to make the sentinel node procedure a radiation free process.
Study design:
A prospective cohort of forty patients with breast cancer and an indication for a sentinel node procedure will be injected with both Technetium (radioisotope) and Magtrace (magnetic). All patients in this study will receive both tracers.
Study population:
Patients of 18 years or older with breast cancer and an indication for a sentinel node procedure will be included. These patients will be recruited by their breast surgeon in the outpatient department of the Breast Care Centre in Zuyderland Medical Centre.
Intervention (if applicable):
Sentinel node procedure using a magnetic tracer next to Technetium.
Main study parameters/endpoints:
The concordance in detection of sentinel nodes by Magtrace and the Technetium tracer, measured by the sensitivity and specificity of Magtrace in detecting sentinel nodes with Technetium tracer as gold standard.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
The goal of this project is evaluating the diagnostic accuracy of Magtrace in the sentinel node procedure. To establish that Magtrace is a non-inferior and a non-radioactive alternative for Technetium with respect to reliability in detecting metastases. The ultimate goal is to make the sentinel node procedure a radiation free process.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective MagTrace patients | Experimental | Procedure: MagSeed and MagTrace in breast cancer patiëntsAll prospective patients will receive a MagSeed in the diagnosed breast cancer tumor. In addition, they will receive MagTrace to detect the sentinel lymph node during surgery. Since this is an experimental study, the patients will also be injected with the golden standard of Technetium tracer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Female patient of 18 years or older.
- Patient with breast cancer and indication for sentinel node procedure.
Key exclusion criteria (3 listed)
- Patients with a previous history of the sentinel node procedure or axillary lymph node dissection in the unilateral breast.
- Unable to comprehend implications and extent of study and sign for informed consent.
- Known allergy or hypersensitivity to iron oxide or dextran.
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 |
|---|---|---|
| MagSeed and MagTrace in breast cancer patiëntsCombining MagSeed and Magtracer to perform a wide local excision breast conserving surgery and sentinel node biopsy. | Procedure or surgery | Prospective MagTrace patients |
Primary outcome
The concordance in detection of sentinel nodes by Magtrace and the Technetium tracer.
Time frame: During surgery
Number of sentinel lymph nodes detected using MagTrace and Technetium and their concordance.
1 secondary outcome
Operation time sentinel node procedure
Time frame: During Surgery
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 1 Apr 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MagSeed and MagTrace in breast cancer patiënts in people with Breast Cancer, run by Zuyderland Medisch Centrum at 1 site in Netherlands.
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 2 inclusion and 3 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 1 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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?
The concordance in detection of sentinel nodes by Magtrace and the Technetium tracer. (time frame: During surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Apr 2022.