Magseed and Sentimag in Surgical Excision of Breast Lesions

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03019445
• Other study ID #: 2016-0459
• Status: Recruiting
• Phase: Phase 4
• First received: January 11, 2017
• Last updated: January 11, 2017
• Start date: January 2017

Study information

• Verified date: January 2017
• Source: M.D. Anderson Cancer Center
• Contact: Kelly K. Hunt, MD, BS
• Phone: 713-745-2840
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 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 may affect the (per investigator discretion).

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Diseases
• Breast Lesion
• Disorders of Breast

Intervention

Device:
• Magseed Marker
Magseed marker localized using the Sentimag system during lumpectomy surgery.

Locations

Country	Name	City	State
United States	University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	Endomagnetics Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retrieval Rate of the Index Lesion and Magseed	The primary endpoint is the % retrieval rate of the index lesion and Magseed in the initial excised specimen. This is defined as the number of subjects in whom the Magseed is localized and the index lesion and Magseed are retrieved in the initial excised specimen, divided by the total number of subjects undergoing surgery for excision of a breast lesion following placement of Magseed in the lesion.	1 day	Yes

External Links

•   University of Texas MD Anderson Cancer Center Website