Disorders of Breast Clinical Trial
Official title:
A Prospective, Open Label, Post Marketing Study of Magseed and Sentimag in Patients Undergoing Surgical Excision of a Breast Lesion
The goal of this clinical research study is to learn more about the safety and effectiveness of a marker called Magseed that is used to help locate lesions during surgery. The Magseed marker is a small metallic marker (smaller than a grain of rice) that is placed in participant's breast close to or inside the lesion by participant's radiologist.
Study Visits:
If participant agrees to take part in this study, participant will have 3 study visits:
Marker Placement Procedure:
If participant can become pregnant, blood (about 1 teaspoon) or urine will be collected for
a pregnancy test before participant's marker placement procedure.
After numbing the skin with a local anesthetic, the Magseed marker will be injected into or
near the lesion in participant's breast, using a needle. The person injecting the Magseed
marker may use an ultrasound or mammogram to position the needle properly.
Lumpectomy Procedure:
After participant has been given general anesthetic to make participant sleep, participant's
doctor will perform surgery (called a lumpectomy) to remove the lesion and the Magseed
marker from participant's breast. As part of the procedure, the doctor will use a handheld
device to scan participant's breast and locate the marker. Participant will sign a separate
consent for the lumpectomy that explains the procedure and its risks.
Following removal of the lesion(s), the study testing is completed and participant's doctor
will continue with participant's standard care in the operating room.
Post-Operative Visit:
Within 2-8 weeks after participant's surgery, participant will return for a routine
follow-up visit. During this visit, participant will be asked questions about any side
effects or injuries participant has had since participant's surgery and about any drugs
participant may be taking. It should take about 10 minutes to answer these questions.
Length of Study Participation:
Participation in this study will be over when participant completes the visit after surgery.
Participant's total time in the study will be about 5-8 weeks.
This is an investigational study. The Magseed marker has been FDA approved to be used in
lumpectomy procedures. It is considered investigational to compare the use of Magseed marker
with information learned from past standard-of-care procedures.
Up to 120 patients will take part in this study. All will be enrolled at MD Anderson.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02923401 -
High-Intensity Interval Training for Women at Heightened Risk for Breast Cancer
|
N/A | |
| Completed |
NCT03020888 -
Magseed Magnetic Marker Localization
|
N/A |