OncologyNCT03988777
Magnetic Seed Localisation for Nonpalpable Breast Lesions
An observational study of Oncology and Breast Cancer, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Screening programs and advances in imaging have led to more breast lesions being diagnosed at an impalpable stage. Multiple localisation techniques for nonpalpable breast lesions have been developed during the past decades. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Oncology, Breast Cancer
- What is being tested?
- Preoperative localisation technique
- Type of treatment
- Medical device
- How many people
- 192 participants
- Where
- 1 siteBelgium
- Study dates
- 10 Sep 2018to 23 May 2019
- 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: Study population includes women (18+) with an impalpable breast lesion suitable for breast conserving surgery.
Who may be able to join
- Breast conserving surgery with preoperative localisation
- Minimum 18 years old
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Magnetic Seed Localisation for Nonpalpable Breast Lesions: a Combined Retrospective and Prospective Analysis
Screening programs and advances in imaging have led to more breast lesions being diagnosed at an impalpable stage. Multiple localisation techniques for nonpalpable breast lesions have been developed during the past decades. Specifically, several alternatives to the golden standard hooked-wire technique have become available, of which magnetic seed localisation is one of the newest approaches. Since September 2018, Magseed® localisation is the standard of care for localising impalpable breast lesions in UZ Leuven. In this study, the oncological safety, the clinical safety and surgeon satisfaction of Magseed® localisation will be assessed and retrospectively compared to hooked-wire localisation.
- Conditions
- Oncology, Breast Cancer
- Being tested
- Preoperative localisation technique
- Keywords
- Breast cancer, Nonpalpable breast lesions, Hooked-wire localisation, Magnetic seed localisation
- Medical subject headings
- Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative localisation techniqueDevice
Impalpable breast lesions are preoperatively localised, either with hooked-wire (retrospective study) or Magseed (prospective study)
| Study group | Role | What they receive |
|---|---|---|
| Prospective Magseed | This cohort includes patients with an impalpable breast lesion that are scheduled for breast conserving surgery with Magseed localisation after September 2018. Their data will be prospectively collected and analysed. Receives: Device: Preoperative localisation technique | |
| Retrospective hooked-wire | This cohort includes patients with an impalpable breast lesion that were scheduled for breast conserving surgery with hooked-wire before September 2018. Their data will be retrospectively collected and analysed. Receives: Device: Preoperative localisation technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participant with device-related adverse events
Measured: Up to three weeks after surgical treatment
Total breast volume resected during breast conserving surgery
Measured: Up to three weeks after surgical treatment
Number of participants with positive surgical margins as assessed by pathological examination of the specimen
Measured: Up to three weeks after surgical treatment
Re-operation rate due to positive surgical margins
Measured: Up to three weeks after surgical treatment
Surgeon satisfaction based on a questionnaire
After surgery, the surgeon will be asked to describe the magnetic seed procedure, choosing between 'easier than hooked-wire' or 'more challenging than hooked-wire'. Moreover, the surgeon wil have the chance to add additional remarks or experiences with this new technique.
Measured: After surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2019
- Study start10 Sep 2018
- Primary completion29 Mar 2019
- Study completion23 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OncologyStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Other
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03988777
- Sponsor's protocol ID
- S61864
- Status last verified
- May 2019
- First submitted
- 29 May 2019
- Last updated
- 17 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Seed Localisation for Nonpalpable Breast Lesions: a Combined Retrospective and Prospective Analysis
- ClinicalTrials.gov ID
- NCT03988777
- Acronym / sponsor ID
- S61864
- Conditions
- Oncology, Breast Cancer
- Keywords
- Breast cancer, Nonpalpable breast lesions, Hooked-wire localisation, Magnetic seed localisation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- KU Leuven
- Study start
- 10 Sep 2018 (actual)
- Primary completion
- 29 Mar 2019 (actual)
- Study completion
- 23 May 2019 (actual)
- First posted
- 17 Jun 2019 (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.
Screening programs and advances in imaging have led to more breast lesions being diagnosed at an impalpable stage. Multiple localisation techniques for nonpalpable breast lesions have been developed during the past decades. Specifically, several alternatives to the golden standard hooked-wire technique have become available, of which magnetic seed localisation is one of the newest approaches. Since September 2018, Magseed® localisation is the standard of care for localising impalpable breast lesions in UZ Leuven. In this study, the oncological safety, the clinical safety and surgeon satisfaction of Magseed® localisation will be assessed and retrospectively compared to hooked-wire localisation.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective Magseed | – | Device: Preoperative localisation techniqueThis cohort includes patients with an impalpable breast lesion that are scheduled for breast conserving surgery with Magseed localisation after September 2018. Their data will be prospectively collected and analysed. |
| Retrospective hooked-wire | – | Device: Preoperative localisation techniqueThis cohort includes patients with an impalpable breast lesion that were scheduled for breast conserving surgery with hooked-wire before September 2018. Their data will be retrospectively collected and analysed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population includes women (18+) with an impalpable breast lesion suitable for breast conserving surgery.
Key inclusion criteria (2 listed)
- Breast conserving surgery with preoperative localisation
- Minimum 18 years old
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Preoperative localisation techniqueImpalpable breast lesions are preoperatively localised, either with hooked-wire (retrospective study) or Magseed (prospective study) | Device | Prospective Magseed, Retrospective hooked-wire |
Primary outcome
Number of participant with device-related adverse events
Time frame: Up to three weeks after surgical treatment
Total breast volume resected during breast conserving surgery
Time frame: Up to three weeks after surgical treatment
Number of participants with positive surgical margins as assessed by pathological examination of the specimen
Time frame: Up to three weeks after surgical treatment
Re-operation rate due to positive surgical margins
Time frame: Up to three weeks after surgical treatment
Surgeon satisfaction based on a questionnaire
Time frame: After surgery
After surgery, the surgeon will be asked to describe the magnetic seed procedure, choosing between 'easier than hooked-wire' or 'more challenging than hooked-wire'. Moreover, the surgeon wil have the chance to add additional remarks or experiences with this new technique.
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 17 Jun 2019.
- 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?
An observational study of Oncology and Breast Cancer, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 0 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 17 Jun 2019. 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 Belgium. 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?
Number of participant with device-related adverse events (time frame: Up to three weeks after surgical treatment). The study lists 5 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 17 Jun 2019.