Magseed and Sentimag in Surgical Excision of Breast Lesions

Last updated: January 11, 2017
Sponsor: M.D. Anderson Cancer Center
Overall Status: Active - Recruiting

Phase

4

Condition

Fibrocystic Breast Disease

Treatment

N/A

Clinical Study ID

NCT03019445
2016-0459
  • Ages > 18
  • Female

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subjects with a breast lesion requiring image-guided localization prior to excision.

  2. Subjects aged 18 years or more at the time of consent.

Exclusion

Exclusion Criteria:

  1. The subject is pregnant or lactating.

  2. Subject has pacemaker or other implantable device in the chest wall.

  3. Subject has current active infection at the implantation site in the breast that mayaffect the (per investigator discretion).

Study Design

Total Participants: 120
Study Start date:
January 01, 2017
Estimated Completion Date:

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.

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.

Connect with a study center

  • University of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

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