Last updated on May 2019

Study the Use of Magseed and Sentimag to Localize Axillary Lymph Nodes

Brief description of study

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 participant's doctor locate lymph nodes that contain cancer under participant's arm during surgery. The Magseed marker is a small metallic marker (smaller than a grain of rice) which is placed in or near the lymph node by participant's radiologist.

This is an investigational study. The Magseed marker has been FDA approved to locate breast tumors. It is investigational to use the marker to locate lymph nodes that contain cancer so that the doctor can remove them.

Up to 50 participants will take part in this study. All will be enrolled at MD Anderson.

Detailed Study Description

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. To take part in this study, participant must not be pregnant.

After numbing the skin with a local anesthetic, the Magseed marker will be injected into or near in or near the lymph node under participant's arm. The person injecting the Magseed marker may use an ultrasound or mammogram to position the needle properly. Participant will leave with a dressing under participant's arm.

Targeted Lymph Node Removal:

After participant has been given general anesthetic to make participant sleep, participant's doctor will perform the lymph node removal procedure. As part of the procedure, the doctor will use a handheld device to scan under participant's arm and locate the marker. Participant will sign a separate consent form that explains the surgical procedure and its risks.

Following removal of the lymph node(s) and the marker, the study testing is completed and participant's doctor will continue with participant's standard care in the operating room.

Post-Operative Visit:

Within 6-22 days after participant's surgery, participant will return for a routine follow-up visit. During visit, participant will be asked questions about any side effects or injuries 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 3-6 weeks.

Clinical Study Identifier: NCT03038152

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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