Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03718455
Recruitment Status : Terminated (Limited operating room availability)
First Posted : October 24, 2018
Results First Posted : October 5, 2020
Last Update Posted : October 5, 2020
Sponsor:
Information provided by (Responsible Party):
Genevieve A. Woodard, Mayo Clinic

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Breast Cancer
Intervention Device: Axillary Magseed
Enrollment 1
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Axillary Magseed
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 1
Completed 1
Not Completed 0
Arm/Group Title Axillary Magseed
Hide Arm/Group Description

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 Number of Baseline Participants 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
60 years old Number Analyzed 1 participants
1
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
1
 100.0%
Male
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
1
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants
1
1.Primary Outcome
Title Evaluate if Magseed is a Viable Alternative to Radioactive Seed as a Localization Method for Biopsy Proven Metastatic Breast Carcinoma Following Neoadjuvant Chemotherapy.
Hide Description 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.
Time Frame 2-22 weeks after placement of the Magseed
Hide Outcome Measure Data
Hide Analysis Population Description
Terminated study due to Limited operating room availability. Data was not analyzed
Arm/Group Title Axillary Magseed
Hide Arm/Group Description:

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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Assess the Success of Retrieval of the Magseed and Biopsy Proven Metastatic Lymph Node in the Operating Room Compared to the Current Practice With the Radioactive Seed.
Hide Description 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.
Time Frame 2-22 weeks after placement of the Magseed
Hide Outcome Measure Data
Hide Analysis Population Description
Terminated study due to Limited operating room availability. Data was not analyzed
Arm/Group Title Axillary Magseed
Hide Arm/Group Description:

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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Determine the Amount of Artifact Created by the Magseed in the Axilla at MRI and Identify Imaging Optimization to Minimize the Artifact Produced by the Magnetic Clip.
Hide Description 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.
Time Frame 2-22 weeks after placement of the Magseed
Hide Outcome Measure Data
Hide Analysis Population Description
Terminated study due to Limited operating room availability. Data was not analyzed
Arm/Group Title Axillary Magseed
Hide Arm/Group Description:

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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse Events were collected from baseline to end of study, approximately two years for the subject.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Axillary Magseed
Hide Arm/Group Description

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.

All-Cause Mortality
Axillary Magseed
Affected / at Risk (%)
Total   0/1 (0.00%) 
Hide Serious Adverse Events
Axillary Magseed
Affected / at Risk (%)
Total   0/1 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Axillary Magseed
Affected / at Risk (%)
Total   0/1 (0.00%) 
Terminated study due to Limited operating room availability. Data was not analyzed
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Genevieve A. Woodard, M.D., Ph.D.
Organization: Mayo Clinic
Phone: 507-538-3945
EMail: Woodard.Genevieve@mayo.edu
Layout table for additonal information
Responsible Party: Genevieve A. Woodard, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03718455    
Other Study ID Numbers: 18-004803
First Submitted: October 15, 2018
First Posted: October 24, 2018
Results First Submitted: September 8, 2020
Results First Posted: October 5, 2020
Last Update Posted: October 5, 2020