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Radiofrequency Identification Technology in Locating Non-palpable Breast Lesions in Patients Undergoing Surgery

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ClinicalTrials.gov Identifier: NCT03202472
Recruitment Status : Completed
First Posted : June 28, 2017
Last Update Posted : September 13, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Brief Summary:
This pilot clinical trial studies radiofrequency technology in locating non-palpable breast lesions in patients undergoing surgery. Placing a miniature radiofrequency tag or microchip in the breast lesion before surgery and using a handheld device to guide doctors during surgery may improve surgical outcomes in patients with non-palpable breast lesions.

Condition or disease Intervention/treatment Phase
Breast Neoplasm Lesion Device: Implanted Medical Device Procedure: Mammography Other: Questionnaire Administration Procedure: Radiofrequency-Guided Localization Procedure: Ultrasonography Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. Evaluate the feasibility of utilizing a new Federal Drug Administration (FDA)-cleared radiofrequency tag for localization of non-palpable breast lesions and provide preliminary data for a larger study.

OUTLINE:

Patients undergo mammogram or ultrasound for image-guided placement of the radiofrequency tag within 30 days of surgery and then undergo radiofrequency-guided localization during surgery.

After completion of study, patients are followed up within 2 weeks.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pilot Trial Evaluating a Miniature Radiofrequency Tag for Localization of Non-palpable Breast Lesions for Surgery
Actual Study Start Date : August 3, 2017
Actual Primary Completion Date : February 1, 2019
Actual Study Completion Date : February 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Diagnostic (radiofrequency-guided localization)
Patients undergo mammogram or ultrasound for image-guided placement of the radiofrequency tag within 30 days of surgery and then undergo radiofrequency-guided localization during surgery.
Device: Implanted Medical Device
Radiofrequency tag
Other Name: IMPLANTED

Procedure: Mammography
Undergo mammogram for image-guided placement of radiofrequency tag

Other: Questionnaire Administration
Ancillary studies

Procedure: Radiofrequency-Guided Localization
Undergo radiofrequency-guided localization
Other Names:
  • RFID Localization
  • RFID-Guided Localization

Procedure: Ultrasonography
Undergo ultrasound for image-guided placement of radiofrequency tag
Other Names:
  • 2-Dimensional Grayscale Ultrasound Imaging
  • 2-Dimensional Ultrasound Imaging
  • 2D-US
  • ULTRASOUND
  • Ultrasound Imaging
  • Ultrasound Test
  • Ultrasound, Medical
  • US




Primary Outcome Measures :
  1. Percentage of patients with successful placement of the radiofrequency tag under radiographic guidance confirmed by mammography [ Time Frame: Up to 1 year ]
    For binary outcomes, exact confidence bounds will be reported for all proportions.

  2. Percentage of patients with successful retrieval of the radiofrequency tag confirmed by specimen radiography [ Time Frame: Up to 1 year ]
    For binary outcomes, exact confidence bounds will be reported for all proportions.


Secondary Outcome Measures :
  1. Days prior to surgery of insertion of marker [ Time Frame: Up to 1 year ]
    For binary outcomes, exact confidence bounds will be reported for all proportions.

  2. Patient experience with image-guided placement of tag as rated by a patient questionnaire [ Time Frame: Up to 1 year ]
    For the three Likert questionnaires, a total score will be computed for each and summary statistics will be reported for the total score and for each item as well as confidence bounds for the median or mean.

  3. Percentage of patients with cancer requiring re-excision [ Time Frame: Up to 1 year ]
    For binary outcomes, exact confidence bounds will be reported for all proportions.

  4. Percentage of patients with documented migration of marker [ Time Frame: Up to 1 year ]
    For binary outcomes, exact confidence bounds will be reported for all proportions.

  5. Percentage of patients with positive margins on initial lumpectomy using radiofrequency identification technology [ Time Frame: Up to 1 year ]
    For binary outcomes, exact confidence bounds will be reported for all proportions.

  6. Radiologist?s experience placing radiofrequency tag compared to wire localization as measured by a radiologist's questionnaire [ Time Frame: Up to 1 year ]
    For the three Likert questionnaires, a total score will be computed for each and summary statistics will be reported for the total score and for each item as well as confidence bounds for the median or mean.

  7. Surgeon?s experience using radiofrequency tag to guide resection compared to wire localization as measured by a surgeon's questionnaire [ Time Frame: Up to 1 year ]
    For the three Likert questionnaires, a total score will be computed for each and summary statistics will be reported for the total score and for each item as well as confidence bounds for the median or mean.

  8. Volume of tissue removed with specimen with tag (not including shave margins, if taken) [ Time Frame: Up to 1 year ]
    For binary outcomes, exact confidence bounds will be reported for all proportions.



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Able to give written informed consent to participate in the study
  • Able to read and write English
  • Patients with breast lesions that are non-palpable that require surgical removal
  • Lesions and/or clip targetable with image guidance

Exclusion Criteria:

  • Multicentric breast cancer
  • Stage IV breast cancer
  • Pregnant or lactating females

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): NCT03202472


Locations
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United States, California
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Maggie DiNome, MD UCLA / Jonsson Comprehensive Cancer Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT03202472     History of Changes
Other Study ID Numbers: 17-000668
NCI-2017-01097 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
UCLA LOCalizer 00 I
17-000668 ( Other Identifier: UCLA / Jonsson Comprehensive Cancer Center )
P30CA016042 ( U.S. NIH Grant/Contract )
First Posted: June 28, 2017    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases