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Trial record 8 of 1628 for:    Recruiting, Not yet recruiting, Available Studies | "Breast Diseases"

Magseed Magnetic Marker Localization

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ClinicalTrials.gov Identifier: NCT03020888
Recruitment Status : Recruiting
First Posted : January 13, 2017
Last Update Posted : February 5, 2018
Sponsor:
Collaborator:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
Endomagnetics Inc

Brief Summary:
The purpose of this post-marketing study is to provide prospective evidence that the Magseed and Sentimag® is effective for lesion localization in patients undergoing surgical excision of a breast lesion and to summarize measures of product safety and performance.

Condition or disease Intervention/treatment Phase
Disorders of Breast Breast Lesions Device: Magseed and Sentimag Not Applicable

Detailed Description:

This is a post-market, prospective, open label, single arm study of Magseed and Sentimag in patients undergoing surgical excision of a breast lesion.

Subjects will have the Magseed marker deployed under imaging guidance up to thirty days prior to surgery.

The Magseed marker will be localized using the Sentimag system during surgery and removed with the lesion.

After the lumpectomy procedure, subjects will be evaluated for safety and patient reported outcomes.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Open Label, Post Marketing Study of Magseed and Sentimag in Patients Undergoing Surgical Excision of a Breast Lesion That Requires Preoperative Radiographic Localization
Study Start Date : January 2017
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : May 2018

Arm Intervention/treatment
Experimental: Magseed and Sentimag

Magseed marker deployed to mark a breast lesion under imaging guidance up to 30 days prior to surgery.

Marker located during surgery using the Sentimag system, and removed with the lesion.

Device: Magseed and Sentimag
Magseed marker and Sentimag probe for lesion localization




Primary Outcome Measures :
  1. Percent retrieval rate of the index lesion and Magseed [ Time Frame: Time of surgery ]
    Percent retrieval rate of the index lesion and Magseed in the initial excised specimen. This is defined as the number of subjects in whom the index lesion and Magseed are retrieved in the initial excised specimen divided by the total number of subjects undergoing surgery.


Secondary Outcome Measures :
  1. Rates of device-related adverse events [ Time Frame: Up to 8 weeks post surgery ]
    Rates of device-related adverse events and device-related serious adverse events

  2. Radiological Ease of Placement [ Time Frame: At time of marker deployment ]
    Radiologist rated ease of marker placement

  3. Radiological Placement Accuracy [ Time Frame: At time of marker deployment ]
    Success rate of Magseed placement relative to the lesion (placement accuracy)

  4. Surgical Localization - Re-excision [ Time Frame: At time of surgery ]
    Overall re-excision rate and re-excision rate necessary to remove the Magseed or targeted lesion

  5. Surgical Localization - ease of localization [ Time Frame: At time of surgery ]
    Surgeon rated ease of localization during surgery

  6. Surgical Localization - duration of localization [ Time Frame: At time of surgery ]
    Duration of lumpectomy procedure

  7. Pathology [ Time Frame: Up to 8 weeks post surgery ]
    Pathologist rated ease of marker identification and retrieval



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with a breast lesion requiring image-guided localization prior to excision.
  • Subjects aged 18 years or more at the time of consent.

Exclusion Criteria:

  • The subject is pregnant or lactating.
  • Subject has pacemaker or other implantable device in the chest wall.
  • Subject has current active infection at the implantation site in the breast (per investigatordiscretion)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03020888


Contacts
Contact: Quentin J Harmer, PhD. 512-370-4933 qharmer@endomag.com
Contact: Clarice L Scofield 612.803.9461 copemc1@gmail.com

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030-4008
Contact: Kelly K Hunt, MD, BS    713-745-2840      
Contact: Jason Love       jklove@mdanderson.org   
Principal Investigator: Kelly K Hunt, MD         
Sub-Investigator: Mediget Teshome, MD         
Sub-Investigator: Elizabeth A Mittendorf, MD         
Sub-Investigator: Alastair M Thompson, MD         
Sub-Investigator: Sarah M DeSnyder, MD         
Sub-Investigator: Dalliah M Black, MD         
Sub-Investigator: Marion E Scoggins, MD         
Sponsors and Collaborators
Endomagnetics Inc
M.D. Anderson Cancer Center

Responsible Party: Endomagnetics Inc
ClinicalTrials.gov Identifier: NCT03020888     History of Changes
Obsolete Identifiers: NCT03019445
Other Study ID Numbers: US-002
First Posted: January 13, 2017    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Breast Diseases
Skin Diseases