Breast Lesions, Disorders of Breast
Conditions
Brief 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.
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.
Interventions
DEVICEMagseed and Sentimag
Magseed marker and Sentimag probe for lesion localization
Sponsors
M.D. Anderson Cancer Center
Endomagnetics Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects with a breast lesion requiring image-guided localization prior to excision. * Subjects aged 18 years or more at the time of consent.
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Participants With Retrieval of Index Lesion and Magseed | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Participants With Radiological Ease of Placement Rated as Very Easy, or Fairly Easy | At the time of marker deployment on average 8.39 minutes | Radiologist were asked to rate ease of marker placement graded from Very easy, Fairly Easy & Difficult after each marker placement. |
| Percentage of Markers With Radiological Placement Accuracy Measured as <5mm to Lesion | At time of marker deployment on average 8.39 minutes | 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 |
| Percentage of Participants With Re-excision | During surgery on average 16 minutes | Overall re-excision rate and re-excision rate necessary to remove the Magseed or targeted lesion |
| Number of Device Related Adverse Events | 8 weeks | Rates of device-related adverse events and device-related serious adverse events |
| Surgical Localization - Duration of Localization | At time of surgery on average 16 minutes | Duration of the lumpectomy procedure, time taken to remove the lesion |
| Percentage of Participants With Marker Retrieval Rated as Fairly or Very Easy | On the day of surgery | Pathologist rated ease of marker identification and retrieval as: 1) Unable to retrieve 2) Difficult 3) Fairly difficult 4)fairly easy 5) very easy |
| Percent of Participants With Surgical Ease of Localization - Rated Fairly or Very Easy | At time of surgery on average 16 minutes | Surgeon rated ease of localization during surgery assessed for each procedure as either very easy, fairly easy, fairly difficult, difficult, unable to localise |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Magseed and Sentimag 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.
Magseed and Sentimag: Magseed marker and Sentimag probe for lesion localization | 107 |
| Total | 107 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Insurance coverage | 2 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Physician Decision | 4 |
| Overall Study | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | Magseed and Sentimag | — |
|---|---|---|
| Age, Continuous | 60.73 Years STANDARD_DEVIATION 11.58 | — |
| BMI | 28.83 kg/m^2 STANDARD_DEVIATION 5.91 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 107 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 107 |
| other Total, other adverse events | 0 / 107 |
| serious Total, serious adverse events | 0 / 107 |
Outcome results
Primary
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.
Time frame: Time of surgery on average 16 minutes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Magseed and Sentimag | Percent of Participants With Retrieval of Index Lesion and Magseed | 100 percentage of participants |
Secondary
Number of Device Related Adverse Events
Rates of device-related adverse events and device-related serious adverse events
Time frame: 8 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Magseed and Sentimag | Number of Device Related Adverse Events | 0 Number of device related adverse events |
Secondary
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
Time frame: At time of marker deployment on average 8.39 minutes
Population: 107 participants had 124 markers placed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Magseed and Sentimag | Percentage of Markers With Radiological Placement Accuracy Measured as <5mm to Lesion | 95.16 percentage of markers |
Secondary
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
Time frame: On the day of surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Magseed and Sentimag | Percentage of Participants With Marker Retrieval Rated as Fairly or Very Easy | 96 percentage of participants |
Secondary
Percentage of Participants With Re-excision
Overall re-excision rate and re-excision rate necessary to remove the Magseed or targeted lesion
Time frame: During surgery on average 16 minutes
Population: malignant breast lesions
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Magseed and Sentimag | Percentage of Participants With Re-excision | 9 percentage of participants |
Secondary
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.
Time frame: At the time of marker deployment on average 8.39 minutes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Magseed and Sentimag | Percent of Participants With Radiological Ease of Placement Rated as Very Easy, or Fairly Easy | 98 % Participants |
Secondary
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
Time frame: At time of surgery on average 16 minutes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Magseed and Sentimag | Percent of Participants With Surgical Ease of Localization - Rated Fairly or Very Easy | 86.9 percentage of participants |
Secondary
Surgical Localization - Duration of Localization
Duration of the lumpectomy procedure, time taken to remove the lesion
Time frame: At time of surgery on average 16 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Magseed and Sentimag | Surgical Localization - Duration of Localization | 5 minutes |