Disorders of BreastNCT03020888
Magseed Magnetic Marker Localization
A study testing Magseed and Sentimag in people with Disorders of Breast and Breast Lesions, run by Endomagnetics Inc at 1 site in United States.
Trial summary
The purpose of this post-marketing study is to provide prospective evidence that the Magseed and Sentimag® is effective for lesion localization in patients undergoing surgical excision of a breast lesion and to summarize measures of product safety and performance. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Disorders of Breast, Breast Lesions
- What is being tested?
- Magseed and Sentimag
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to Jul 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Subjects with a breast lesion requiring image-guided localization prior to excision.
- Subjects aged 18 years or more at the time of consent.
Who cannot join
- The subject is pregnant or lactating.
- Subject has pacemaker or other implantable device in the chest wall.
- Subject has current active infection at the implantation site in the breast (per investigatordiscretion)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030-4008
About this study
Official title: A Prospective, Open Label, Post Marketing Study of Magseed and Sentimag in Patients Undergoing Surgical Excision of a Breast Lesion That Requires Preoperative Radiographic Localization
The purpose of this post-marketing study is to provide prospective evidence that the Magseed and Sentimag® is effective for lesion localization in patients undergoing surgical excision of a breast lesion and to summarize measures of product safety and performance.
Read the detailed description
This is a post-market, prospective, open label, single arm study of Magseed and Sentimag in patients undergoing surgical excision of a breast lesion.
Subjects will have the Magseed marker deployed under imaging guidance up to thirty days prior to surgery.
The Magseed marker will be localized using the Sentimag system during surgery and removed with the lesion.
After the lumpectomy procedure, subjects will be evaluated for safety and patient reported outcomes.
- Conditions
- Disorders of Breast, Breast Lesions
- Being tested
- Magseed and Sentimag
- Medical subject headings
- Breast Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magseed and SentimagDevice
Magseed marker and Sentimag probe for lesion localization
| Study group | Role | What they receive |
|---|---|---|
| Magseed and Sentimag | Experimental | Magseed marker deployed to mark a breast lesion under imaging guidance up to 30 days prior to surgery.
Marker located during surgery using the Sentimag system, and removed with the lesion. Receives: Device: Magseed and Sentimag |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Participants With Retrieval of Index Lesion and Magseed
Percent retrieval rate of the index lesion and Magseed in the initial excised specimen. This is defined as the number of subjects in whom the index lesion and Magseed are retrieved in the initial excised specimen divided by the total number of subjects undergoing surgery.
Measured: Time of surgery on average 16 minutes
Secondary outcomes (7)
Number of Device Related Adverse Events
Rates of device-related adverse events and device-related serious adverse events
Measured: 8 weeks
Percent of Participants With Radiological Ease of Placement Rated as Very Easy, or Fairly Easy
Radiologist were asked to rate ease of marker placement graded from Very easy, Fairly Easy \& Difficult after each marker placement.
Measured: At the time of marker deployment on average 8.39 minutes
Percentage of Markers With Radiological Placement Accuracy Measured as <5mm to Lesion
Success rate of Magseed placement relative to the lesion (placement accuracy) measured as <5mm to lesion; 5-10mm to lesion; >10 mm to the target
Measured: At time of marker deployment on average 8.39 minutes
Percentage of Participants With Re-excision
Overall re-excision rate and re-excision rate necessary to remove the Magseed or targeted lesion
Measured: During surgery on average 16 minutes
Percent of Participants With Surgical Ease of Localization - Rated Fairly or Very Easy
Surgeon rated ease of localization during surgery assessed for each procedure as either very easy, fairly easy, fairly difficult, difficult, unable to localise
Measured: At time of surgery on average 16 minutes
Surgical Localization - Duration of Localization
Duration of the lumpectomy procedure, time taken to remove the lesion
Measured: At time of surgery on average 16 minutes
Percentage of Participants With Marker Retrieval Rated as Fairly or Very Easy
Pathologist rated ease of marker identification and retrieval as: 1) Unable to retrieve 2) Difficult 3) Fairly difficult 4)fairly easy 5) very easy
Measured: On the day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionFeb 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Disorders of BreastStudies 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endomagnetics Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- M.D. Anderson Cancer Center
- Responsible party
- Sponsor
- Investigators
- Kelly Hunt, MD, Principal investigator, MD Anderson
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03020888
- Sponsor's protocol ID
- US-002
- Status last verified
- Jan 2021
- First submitted
- 10 Jan 2017
- Last updated
- 4 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open Label, Post Marketing Study of Magseed and Sentimag in Patients Undergoing Surgical Excision of a Breast Lesion That Requires Preoperative Radiographic Localization
- ClinicalTrials.gov ID
- NCT03020888
- Acronym / sponsor ID
- US-002
- Conditions
- Disorders of Breast, Breast Lesions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Endomagnetics IncIndustry (pharma, biotech, devices)
- Collaborators
- M.D. Anderson Cancer Center
- Study start
- Jan 2017 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 13 Jan 2017 (estimated)
- Results
- Posted 15 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this post-marketing study is to provide prospective evidence that the Magseed and Sentimag® is effective for lesion localization in patients undergoing surgical excision of a breast lesion and to summarize measures of product safety and performance.
Detailed description
This is a post-market, prospective, open label, single arm study of Magseed and Sentimag in patients undergoing surgical excision of a breast lesion.
Subjects will have the Magseed marker deployed under imaging guidance up to thirty days prior to surgery.
The Magseed marker will be localized using the Sentimag system during surgery and removed with the lesion.
After the lumpectomy procedure, subjects will be evaluated for safety and patient reported outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Magseed and Sentimag | Experimental | Device: Magseed and SentimagMagseed marker deployed to mark a breast lesion under imaging guidance up to 30 days prior to surgery. Marker located during surgery using the Sentimag system, and removed with the lesion. |
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)
- Subjects with a breast lesion requiring image-guided localization prior to excision.
- Subjects aged 18 years or more at the time of consent.
Key exclusion criteria (3 listed)
- The subject is pregnant or lactating.
- Subject has pacemaker or other implantable device in the chest wall.
- Subject has current active infection at the implantation site in the breast (per investigatordiscretion)
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 SentimagMagseed marker and Sentimag probe for lesion localization | Device | Magseed and Sentimag |
Primary outcome
Percent of Participants With Retrieval of Index Lesion and Magseed
Time frame: Time of surgery on average 16 minutes
Percent retrieval rate of the index lesion and Magseed in the initial excised specimen. This is defined as the number of subjects in whom the index lesion and Magseed are retrieved in the initial excised specimen divided by the total number of subjects undergoing surgery.
7 secondary outcomes
Number of Device Related Adverse Events
Time frame: 8 weeks
Percent of Participants With Radiological Ease of Placement Rated as Very Easy, or Fairly Easy
Time frame: At the time of marker deployment on average 8.39 minutes
Percentage of Markers With Radiological Placement Accuracy Measured as <5mm to Lesion
Time frame: At time of marker deployment on average 8.39 minutes
Percentage of Participants With Re-excision
Time frame: During surgery on average 16 minutes
Percent of Participants With Surgical Ease of Localization - Rated Fairly or Very Easy
Time frame: At time of surgery on average 16 minutes
Surgical Localization - Duration of Localization
Time frame: At time of surgery on average 16 minutes
Percentage of Participants With Marker Retrieval Rated as Fairly or Very Easy
Time frame: On the day of surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Kelly Hunt, MD principal investigator
MD Anderson
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 Sentimag in people with Disorders of Breast and Breast Lesions, run by Endomagnetics Inc at 1 site in United States.
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 4 Feb 2021. 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 United States. 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?
Yes. Results are posted in the registry (first posted 15 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent of Participants With Retrieval of Index Lesion and Magseed (time frame: Time of surgery on average 16 minutes). 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 4 Feb 2021.