Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

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.

Implanted Medical Device

Undergo mammogram for image-guided placement of radiofrequency tag

Mammography

Questionnaire Administration

Undergo radiofrequency-guided localization

Radiofrequency (RFID) -Guided Localization

Undergo ultrasound for image-guided placement of radiofrequency tag

Ultrasonography

Maggie DiNome, MD

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.

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.

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

Pilot Trial Evaluating a Miniature Radiofrequency Tag for Localization of Non-palpable Breast Lesions for Surgery

Patients with successful radiofrequency tag placement

Patients with successful radiofrequency tag retrieval.

Mean number of days before surgery that radiofrequency tag was placed.

The patient experience with image-guided placement of the radio frequency Identification (RFID) tag.This assessments was captured using Likert-type questionnaires. Individual question responses for the patient and physician questionnaires ranged from 1 to 5 with the score of 5 representing the maximum positive or favorable response to each question. The following choices were included in each questionnaire:

1. Strongly disagree
2. Disagree
3. Neutral
4. Agree
5. Strongly Agree

Responses of the individual scales were added to create a total score, which would include a possible total range of 5 to a maximum of 25 points. 25 is the maximum positive or favorable response.

Movement of radiofrequency tag from point of placement

Patients with margins of excisable tissue remaining.

The radiologist's experience with image-guided placement of the RFID tag.This assessments was captured using Likert-type questionnaires. Individual question responses for the patient and physician questionnaires ranged from 1 to 5 with the score of 5 representing the maximum positive or favorable response to each question. The following choices were included in each questionnaire:

1. Strongly disagree
2. Disagree
3. Neutral
4. Agree
5. Strongly Agree

Responses of the individual scales were added to create a total score, which would include a possible total range of 5 to a maximum of 25 points. 25 is the maximum positive or favorable response.

The surgeon's experience with image-guided placement of the RFID tag.This assessments was captured using Likert-type questionnaires. Individual question responses for the patient and physician questionnaires ranged from 1 to 5 with the score of 5 representing the maximum positive or favorable response to each question. The following choices were included in each questionnaire:

1. Strongly disagree
2. Disagree
3. Neutral
4. Agree
5. Strongly Agree

Responses of the individual scales were added to create a total score, which would include a possible total range of 5 to a maximum of 25 points. 25 is the maximum positive or favorable response.

Amount of tissue removed with radiofrequency tag.

AstraZeneca

Jonsson Comprehensive Cancer Center

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.

Implanted Medical Device: Radiofrequency tag

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

Questionnaire Administration: Ancillary studies

Radiofrequency-Guided Localization: Undergo radiofrequency-guided localization

Ultrasonography: Undergo ultrasound for image-guided placement of radiofrequency tag

Diagnostic (Radiofrequency-guided Localization)

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Spots Global Cancer Trial Database for Radiofrequency Identification Technology in Locating Non-palpable Breast Lesions in Patients Undergoing Surgery

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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