Breast CancerMagTrace2NCT05637528
Evaluating the Use of Magnetic Resonance Imaging and Contrast Enhanced Mammography After MagTrace® Use
An observational study of Breast Cancer, run by Zuyderland Medisch Centrum.
Trial summary
Rationale: MagTrace® will be implemented as standard of care for sentinel lymph node biopsy, since it has several advantages compared to a radioactive technique. However, MagTrace® is known to interfere with MRI during follow-up imaging when using 2 mL. 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?
- MRI
- Type of treatment
- Injection or infusion
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 23 Nov 2022to 31 Mar 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 who participated in the previous MagTrace study will be included. All patients will be approached before their 1-year follow-up appointment at the radiology department. Patients will be informed by telephone by the coordinating investigator. If they are interested in this study, the patients will receive the patient information folder. Forty patients were included in the MagTrace study, so depending on the participants' willingness to participate in this subsequent trial, up to 40 patients will participate.
Who may be able to join
- Female patients of 18 years and older.
- Previously underwent sentinel lymph node biopsy using MagTrace®.
- Undergoing standard follow-up for previous breast cancer
Who cannot join
- Unable to comprehend the extend and implications of the study and sign for informed consent.
- Standard MRI exclusion criteria:
- Implantable (electrical) devices (e.g., pacemaker, cochlear implants, neurostimulator);
- Any other metal implants;
- Claustrophobia;
- MR-incompatible prosthetic heart valves.
- Standard CEM exclusion criteria:
- Breast implants.
Trial locations and contacts
No sites are listed yet.
About this study
Rationale: MagTrace® will be implemented as standard of care for sentinel lymph node biopsy, since it has several advantages compared to a radioactive technique. However, MagTrace® is known to interfere with MRI during follow-up imaging when using 2 mL. No data is available for patients who received 1 mL of MagTrace®, as is described in our current protocol. A contrast enhanced mammography (CEM) could be an alternative for MRI if it still shows artefacts.
Objective: The primary objective in this trial is to evaluate the use of MRI and contrast enhanced mammography after using MagTrace® to perform a sentinel node biopsy.
Read more
Study design: Prospective trial in an outpatient clinic setting.
Study population: Patients who were included in the previous MagTrace study will be asked to participate in this subsequent trial.
Study procedure: Participants will undergo MRI and CEM as standard 1-year follow-up. Since the MagTrace study started in August 2021 and finished in February 2022, this trial will start August 2022 to February 2023.
Main study parameters/endpoints: To evaluate the use of MRI and CEM, the following primary endpoints will be assessed: Visibility and size of artefacts undergoing MRI and CEM and its consequences of the quality for image assessment.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Since MagTrace® will be implemented as standard localisation technique for breast conserving surgery and sentinel lymph node biopsy in Zuyderland MC, the information obtained from this trial is essential for the follow-up planning of all breast cancer patients. Therefore, the burden for the patients (undergoing extra imaging) will be in proportion to the added value of this trial.
- Conditions
- Breast Cancer
- Being tested
- MRI
- Keywords
- Magtrace, MRI, Mammography
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDiagnostic test
Also called Mammography
Patients will undergo an MRI and mammography one year after MagTrace injections
| Study group | Role | What they receive |
|---|---|---|
| MagTrace patients | Patients who underwent sentinel lymph node biopsy with MagTrace one year ago. Receives: Diagnostic Test: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Are there any artefacts visible when undergoing an MRI?
Visible artefacts on MRI
Measured: One year after surgery
Are there any artefacts visible when undergoing a CEM?
Visible artefacts on CEM
Measured: One year after surgery
Secondary outcomes (2)
Size of the possible artefact.
Size of the artefacts on MRI and mammography
Measured: One year after surgery
The possibility to assess the imaging by a trained radiologist
The radiologist will score the assessability using a 4 point scoring system:
- No artefact
- Good diagnostic quality
- Impaired but still readable
- Hampered clinical assessment
Measured: One year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start23 Nov 2022 (estimated)
- Primary completion23 Feb 2023 (estimated)
- Study completion31 Mar 2023 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zuyderland Medisch Centrum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yvonne Vissers, Zuyderland Medisch Centrum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05637528
- Sponsor's protocol ID
- NL82061.096.22
- Acronym
- MagTrace2
- Status last verified
- Nov 2022
- First submitted
- 23 Nov 2022
- Last updated
- 5 Dec 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 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Use of Magnetic Resonance Imaging and Contrast Enhanced Mammography After MagTrace® Use
- ClinicalTrials.gov ID
- NCT05637528
- Acronym / sponsor ID
- MagTrace2 / NL82061.096.22
- Conditions
- Breast Cancer
- Keywords
- Magtrace, MRI, Mammography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Zuyderland Medisch CentrumUniversity, hospital or other
- Study start
- 23 Nov 2022 (estimated)
- Primary completion
- 23 Feb 2023 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 5 Dec 2022 (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: MagTrace® will be implemented as standard of care for sentinel lymph node biopsy, since it has several advantages compared to a radioactive technique. However, MagTrace® is known to interfere with MRI during follow-up imaging when using 2 mL. No data is available for patients who received 1 mL of MagTrace®, as is described in our current protocol. A contrast enhanced mammography (CEM) could be an alternative for MRI if it still shows artefacts.
Objective: The primary objective in this trial is to evaluate the use of MRI and contrast enhanced mammography after using MagTrace® to perform a sentinel node biopsy.
Study design: Prospective trial in an outpatient clinic setting.
Study population: Patients who were included in the previous MagTrace study will be asked to participate in this subsequent trial.
Study procedure: Participants will undergo MRI and CEM as standard 1-year follow-up. Since the MagTrace study started in August 2021 and finished in February 2022, this trial will start August 2022 to February 2023.
Main study parameters/endpoints: To evaluate the use of MRI and CEM, the following primary endpoints will be assessed: Visibility and size of artefacts undergoing MRI and CEM and its consequences of the quality for image assessment.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Since MagTrace® will be implemented as standard localisation technique for breast conserving surgery and sentinel lymph node biopsy in Zuyderland MC, the information obtained from this trial is essential for the follow-up planning of all breast cancer patients. Therefore, the burden for the patients (undergoing extra imaging) will be in proportion to the added value of this trial.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MagTrace patients | – | Diagnostic Test: MRIPatients who underwent sentinel lymph node biopsy with MagTrace one year ago. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who participated in the previous MagTrace study will be included. All patients will be approached before their 1-year follow-up appointment at the radiology department. Patients will be informed by telephone by the coordinating investigator. If they are interested in this study, the patients will receive the patient information folder. Forty patients were included in the MagTrace study, so depending on the participants' willingness to participate in this subsequent trial, up to 40 patients will participate.
Key inclusion criteria (3 listed)
- Female patients of 18 years and older.
- Previously underwent sentinel lymph node biopsy using MagTrace®.
- Undergoing standard follow-up for previous breast cancer
Key exclusion criteria (8 listed)
- Unable to comprehend the extend and implications of the study and sign for informed consent.
- Standard MRI exclusion criteria:
- Standard CEM exclusion criteria:
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 |
|---|---|---|
| MRIAlso: MammographyPatients will undergo an MRI and mammography one year after MagTrace injections | Diagnostic test | MagTrace patients |
Primary outcome
Are there any artefacts visible when undergoing an MRI?
Time frame: One year after surgery
Visible artefacts on MRI
Are there any artefacts visible when undergoing a CEM?
Time frame: One year after surgery
Visible artefacts on CEM
2 secondary outcomes
Size of the possible artefact.
Time frame: One year after surgery
The possibility to assess the imaging by a trained radiologist
Time frame: One year after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Zuyderland Medisch Centrum.
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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 5 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Merel Spiekerman van Weezelenburg, MD (088 459 7777, m.spiekermanvanweezelenburg@zuyderland.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Are there any artefacts visible when undergoing an MRI? (time frame: One year after surgery). The study lists 2 primary outcomes in all. 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 5 Dec 2022.