Trial Outcomes & Findings for Evaluation of Magseed as Localization Device for Biopsy Proven Metastatic Axillary Lymph Nodes (NCT NCT03718455)

NCT ID: NCT03718455

Last Updated: 2020-10-05

Results Overview

The rate of successful placement of the Magseed into the axilla in the radiology department will be measured. Any substantial barriers to placement compared to the investigators' current clinical practice with the radioactive seed will be subjectively gathered from the radiologist and will be reported on a case-by-case basis.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 1 participants
• Primary outcome timeframe: 2-22 weeks after placement of the Magseed
• Results posted on: 2020-10-05

Participant Flow

Participant milestones

Measure	Axillary Magseed Single cohort of twenty women receiving neoadjuvant chemotherapy with breast cancer will have a Magseed inserted into a biopsy proven metastatic axillary lymph node for pre-surgical localization. Axillary Magseed: The Magseed will replace the investigators' current clinical practice of using radioactive seeds in women receiving neoadjuvant chemotherapy.
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Magseed as Localization Device for Biopsy Proven Metastatic Axillary Lymph Nodes

Baseline characteristics by cohort

Measure	Axillary Magseed n=1 Participants Single cohort of twenty women receiving neoadjuvant chemotherapy with breast cancer will have a Magseed inserted into a biopsy proven metastatic axillary lymph node for pre-surgical localization. Axillary Magseed: The Magseed will replace the investigators' current clinical practice of using radioactive seeds in women receiving neoadjuvant chemotherapy.
Age, Customized 60 years old	1 participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 2-22 weeks after placement of the Magseed

Population: Terminated study due to Limited operating room availability. Data was not analyzed

The rate of successful placement of the Magseed into the axilla in the radiology department will be measured. Any substantial barriers to placement compared to the investigators' current clinical practice with the radioactive seed will be subjectively gathered from the radiologist and will be reported on a case-by-case basis.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 2-22 weeks after placement of the Magseed

Population: Terminated study due to Limited operating room availability. Data was not analyzed

The rate of successful retrieval of the Magseed from the axilla in the operating room will be measured. Any substantial barriers to retrieval compared to the investigators' current clinical practice with the radioactive seed will be subjectively gathered from the surgeon and will be reported on a case-by-cases basis.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2-22 weeks after placement of the Magseed

Population: Terminated study due to Limited operating room availability. Data was not analyzed

The maximum dimension of the susceptibility artifact will be measured in centimeters with the investigator's current clinical MRI protocols. Additional MRI sequences with susceptibility artifact suppression techniques will be conducted and the maximum dimension of the susceptibility artifact will be measured in centimeters. Differences in these measurements will be analyzed.

Outcome measures

Outcome data not reported

Adverse Events

Axillary Magseed

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

Genevieve A. Woodard, M.D., Ph.D.

Mayo Clinic

Phone: 507-538-3945

Email: Woodard.Genevieve@mayo.edu

Results disclosure agreements

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