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Trial Outcomes & Findings for Magnetic Seed Localisation of Breast Cancers (NCT NCT02635737)

NCT ID: NCT02635737

Last Updated: 2021-01-15

Results Overview

Migration of the device\>10mm between mammograms, clip position \>40mm from target lesion

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

29 participants

Primary outcome timeframe

1-4 weeks from placement

Results posted on

2021-01-15

Participant Flow

Participant milestones

Participant milestones
Measure
Sentimark Device Placement
Sentimark device placed in women having mastectomy surgery Sentimark: Placement of a metallic clip with paramagnetic properties for tumour localisation
Overall Study
STARTED
29
Overall Study
COMPLETED
28
Overall Study
NOT COMPLETED
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Sentimark Device Placement
Sentimark device placed in women having mastectomy surgery Sentimark: Placement of a metallic clip with paramagnetic properties for tumour localisation
Overall Study
Protocol Violation
1

Baseline Characteristics

Magnetic Seed Localisation of Breast Cancers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Sentimark Device Placement
n=28 Participants
Sentimark device placed in women having mastectomy surgery Sentimark: Placement of a metallic clip with paramagnetic properties for tumour localisation
Age, Categorical
<=18 years
0 Participants
n=39 Participants
Age, Categorical
Between 18 and 65 years
12 Participants
n=39 Participants
Age, Categorical
>=65 years
16 Participants
n=39 Participants
Age, Continuous
54 years
n=39 Participants
Sex: Female, Male
Female
28 Participants
n=39 Participants
Sex: Female, Male
Male
0 Participants
n=39 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=39 Participants
Race (NIH/OMB)
Asian
0 Participants
n=39 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=39 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=39 Participants
Race (NIH/OMB)
White
0 Participants
n=39 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=39 Participants
Race (NIH/OMB)
Unknown or Not Reported
28 Participants
n=39 Participants
Region of Enrollment
United Kingdom
28 participants
n=39 Participants

PRIMARY outcome

Timeframe: 1-4 weeks from placement

Population: migration of seed

Migration of the device\>10mm between mammograms, clip position \>40mm from target lesion

Outcome measures

Outcome measures
Measure
Sentimark Device Placement
n=28 Participants
Sentimark device placed in women having mastectomy surgery Sentimark: Placement of a metallic clip with paramagnetic properties for tumour localisation
Migration of Sentimark Device
100 percentage of Magseed migrating >10mm

SECONDARY outcome

Timeframe: within 60 minutes of seed placement

distance of the marker (seed) on radiographic imaging from the intended site of placement (e.g. lesion, marker clip, calcification) in mm

Outcome measures

Outcome measures
Measure
Sentimark Device Placement
n=28 Participants
Sentimark device placed in women having mastectomy surgery Sentimark: Placement of a metallic clip with paramagnetic properties for tumour localisation
Accuracy of Initial Placement
0 mm
Standard Error 0.1

SECONDARY outcome

Timeframe: within 60 minutes of seed placement

Population: all 28 womens markers were within the target area

The target area will be detected by mammography on the day of surgery and is defined as within 10mm of the target lesion

Outcome measures

Outcome measures
Measure
Sentimark Device Placement
n=28 Participants
Sentimark device placed in women having mastectomy surgery Sentimark: Placement of a metallic clip with paramagnetic properties for tumour localisation
Percentage Magnetic Markers (Seeds) Within Target Area;
100 percentage of womens markers were within

SECONDARY outcome

Timeframe: within 60 minutes of seed placement

Marker (seed) depth to the nearest skin surface will be estimated sonographically in mm

Outcome measures

Outcome measures
Measure
Sentimark Device Placement
n=28 Participants
Sentimark device placed in women having mastectomy surgery Sentimark: Placement of a metallic clip with paramagnetic properties for tumour localisation
Depth of Marker (Seed)
16 mm
Interval 3.5 to 30.0

SECONDARY outcome

Timeframe: Within 60 minutes of seed placement

ability to detect the marker (seed) with Sentimag - this will be recorded whether the count is detectable on the Sentimag detector

Outcome measures

Outcome measures
Measure
Sentimark Device Placement
n=28 Participants
Sentimark device placed in women having mastectomy surgery Sentimark: Placement of a metallic clip with paramagnetic properties for tumour localisation
Number of Seeds Detectable on the Sentimag Detector
28 Participants

SECONDARY outcome

Timeframe: within 4 weeks of seed placement

percentage of seeds showing foreign body reaction histopathologically

Outcome measures

Outcome measures
Measure
Sentimark Device Placement
n=18 Participants
Sentimark device placed in women having mastectomy surgery Sentimark: Placement of a metallic clip with paramagnetic properties for tumour localisation
Host Response to Implanted Seed Device
50 percentage of seeds showing fb reaction

OTHER_PRE_SPECIFIED outcome

Timeframe: Through study completion, an average of six weeks

The number of treatment related adverse and serious adverse events will be recorded as a number of events and a percentage of participants who experienced an Adverse Event

Outcome measures

Outcome measures
Measure
Sentimark Device Placement
n=28 Participants
Sentimark device placed in women having mastectomy surgery Sentimark: Placement of a metallic clip with paramagnetic properties for tumour localisation
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: At Surgery

Population: breast weight

Mastectomy weight - breast weight

Outcome measures

Outcome measures
Measure
Sentimark Device Placement
n=28 Participants
Sentimark device placed in women having mastectomy surgery Sentimark: Placement of a metallic clip with paramagnetic properties for tumour localisation
Mastectomy Weight
833 grams
Interval 126.0 to 2600.0

Adverse Events

Sentimark Device Placement

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mr James Harvey

UHSM

Phone: 01612914436

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place