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Radiofrequency-Guided Localization in Patients With Abnormal Breast Tissue Undergoing Lumpectomy

Primary Purpose

Breast Neoplasm

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lumpectomy
Questionnaire Administration
Radiofrequency-Guided Localization
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Neoplasm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Have had stereotactic or ultrasound-guided biopsy with marker placement
  • Have a lesion or biopsy marker that is visible under ultrasound
  • Have a surgical target =< 6 cm from the skin when lying supine
  • Have a discreet surgical target
  • Have a lesion in which the center/focal area is defined
  • Have the ability to understand and the willingness to sign a written informed consent document
  • Eastern Cooperative Oncology Group (ECOG)/Karnofsky performance status will not be used as an inclusion criterion
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  • Require more than one localization needle for localization of the surgical target (bracket localization)
  • Have undergone previous open surgical biopsy, lumpectomy, or mastectomy in the operative breast
  • Have a prosthesis/implant in the operative breast
  • Have a cardiac pacemaker or defibrillator device
  • Be contraindicated for surgery
  • Be pregnant

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Diagnostic (radiofrequency-guided localization)

    Arm Description

    Patients undergo radiofrequency-guided localization comprising RFID tag placement before lumpectomy and interactive detection of tag using RFID reader during lumpectomy.

    Outcomes

    Primary Outcome Measures

    Localization success, defined as the surgical target visualized in the removed specimen AND the RFID tag removed from the patient's breast
    Will be summarized using descriptive statistics, including total numbers, percentages, means, and proportions.

    Secondary Outcome Measures

    Feedback solicited from the radiologist and surgeon
    Feedback solicited from the radiologist and surgeon will be summarized using qualitative methods. Each questionnaire will be reviewed for both positive and negative responses and summarized.

    Full Information

    First Posted
    April 28, 2015
    Last Updated
    January 31, 2017
    Sponsor
    Stanford University
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02432118
    Brief Title
    Radiofrequency-Guided Localization in Patients With Abnormal Breast Tissue Undergoing Lumpectomy
    Official Title
    A Feasibility Study of Radiofrequency Identification (RFID) Localization of Breast Lesions
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2017
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Insufficient resources
    Study Start Date
    May 2015 (undefined)
    Primary Completion Date
    February 2016 (Anticipated)
    Study Completion Date
    May 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Stanford University
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This pilot clinical trial studies the use of the radiofrequency-guided localization in patients with abnormal breast tissue undergoing lumpectomy (a type of breast-sparing surgery). The radiofrequency identification localization system consists of an implantable radiofrequency identification tag and a hand-held radiofrequency reader to mark abnormal breast tissue before surgery and later surgically retrieve them. Radiofrequency-guided localization may make it easier to find and remove abnormal breast tissue during lumpectomy.
    Detailed Description
    PRIMARY OBJECTIVES: I. To obtain human clinical data in order to demonstrate that the Radiofrequency Identification (RFID) Localization System performs as intended as a localization device for marking and retrieving a surgical target in the breast. SECONDARY OBJECTIVES: I. To solicit feedback from the radiologists and surgeons regarding the process and use of the RFID system. OUTLINE: Patients undergo radiofrequency-guided localization comprising RFID tag placement before lumpectomy and interactive detection of tag using RFID reader during lumpectomy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Neoplasm

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Diagnostic (radiofrequency-guided localization)
    Arm Type
    Experimental
    Arm Description
    Patients undergo radiofrequency-guided localization comprising RFID tag placement before lumpectomy and interactive detection of tag using RFID reader during lumpectomy.
    Intervention Type
    Procedure
    Intervention Name(s)
    Lumpectomy
    Other Intervention Name(s)
    Lumpectomy of Breast, partial mastectomy
    Intervention Description
    Undergo lumpectomy
    Intervention Type
    Other
    Intervention Name(s)
    Questionnaire Administration
    Intervention Description
    Ancillary studies
    Intervention Type
    Procedure
    Intervention Name(s)
    Radiofrequency-Guided Localization
    Intervention Description
    Undergo radiofrequency-guided localization
    Primary Outcome Measure Information:
    Title
    Localization success, defined as the surgical target visualized in the removed specimen AND the RFID tag removed from the patient's breast
    Description
    Will be summarized using descriptive statistics, including total numbers, percentages, means, and proportions.
    Time Frame
    At time of surgery
    Secondary Outcome Measure Information:
    Title
    Feedback solicited from the radiologist and surgeon
    Description
    Feedback solicited from the radiologist and surgeon will be summarized using qualitative methods. Each questionnaire will be reviewed for both positive and negative responses and summarized.
    Time Frame
    Up to 12 months after lumpectomy

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Have had stereotactic or ultrasound-guided biopsy with marker placement Have a lesion or biopsy marker that is visible under ultrasound Have a surgical target =< 6 cm from the skin when lying supine Have a discreet surgical target Have a lesion in which the center/focal area is defined Have the ability to understand and the willingness to sign a written informed consent document Eastern Cooperative Oncology Group (ECOG)/Karnofsky performance status will not be used as an inclusion criterion Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: Require more than one localization needle for localization of the surgical target (bracket localization) Have undergone previous open surgical biopsy, lumpectomy, or mastectomy in the operative breast Have a prosthesis/implant in the operative breast Have a cardiac pacemaker or defibrillator device Be contraindicated for surgery Be pregnant
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jafi Lipson
    Organizational Affiliation
    Stanford University Hospitals and Clinics
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Radiofrequency-Guided Localization in Patients With Abnormal Breast Tissue Undergoing Lumpectomy

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