Radiofrequency Identification Technology in Locating Non-palpable Breast Lesions in Patients Undergoing Surgery
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Breast Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 19 - Any |
| Updated: | 3/1/2019 |
| Start Date: | August 3, 2017 |
| End Date: | October 1, 2021 |
Pilot Trial Evaluating a Miniature Radiofrequency Tag for Localization of Non-palpable Breast Lesions for Surgery
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.
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.
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.
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
We found this trial at
1
site
Los Angeles, California 90095
Principal Investigator: Maggie L. DiNome
Phone: 424-259-8791
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