Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03202472
Other study ID # 17-000668
Secondary ID NCI-2017-01097UC
Status Completed
Phase N/A
First received
Last updated
Start date August 3, 2017
Est. completion date February 1, 2019

Study information

Verified date June 2020
Source Jonsson Comprehensive Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date February 1, 2019
Est. primary completion date January 12, 2018
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Implanted Medical Device
Radiofrequency tag
Procedure:
Mammography
Undergo mammogram for image-guided placement of radiofrequency tag
Other:
Questionnaire Administration
Ancillary studies
Procedure:
Radiofrequency (RFID) -Guided Localization
Undergo radiofrequency-guided localization
Ultrasonography
Undergo ultrasound for image-guided placement of radiofrequency tag

Locations

Country Name City State
United States UCLA / Jonsson Comprehensive Cancer Center Los Angeles California

Sponsors (2)

Lead Sponsor Collaborator
Jonsson Comprehensive Cancer Center AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Patients With Successful Placement of the Radiofrequency Tag Under Radiographic Guidance Confirmed by Mammography Patients with successful radiofrequency tag placement at time of device placement, confirmed by mammography
Primary Patients With Successful Retrieval of the Radiofrequency Tag Confirmed by Specimen Radiography Patients with successful radiofrequency tag retrieval. at time of surgery, within 30 days of tag implant
Secondary Days Prior to Surgery of Insertion of Marker Mean number of days before surgery that radiofrequency tag was placed. Up to 30 days prior to surgery
Secondary Patient Experience With Image-guided Placement of Tag as Rated by a Patient Questionnaire 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:
Strongly disagree
Disagree
Neutral
Agree
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.
within 24 hours of device placement
Secondary Patients With Cancer Requiring Re-excision Patients requiring re-excision. up to 4 weeks post initial surgery
Secondary Patients With Documented Migration of Marker Movement of radiofrequency tag from point of placement at time of surgery, within 30 days of tag implant
Secondary Patients With Positive Margins on Initial Lumpectomy Using Radiofrequency Identification Technology Patients with margins of excisable tissue remaining. at time of pathologic evaluation of surgical specimen, within 4 weeks of surgery
Secondary Radiologist's Experience Placing Radiofrequency Tag Compared to Wire Localization as Measured by a Radiologist's Questionnaire 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:
Strongly disagree
Disagree
Neutral
Agree
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.
within 24 hours of device placement
Secondary Surgeon's Experience Using Radiofrequency Tag to Guide Resection Compared to Wire Localization as Measured by a Surgeon's Questionnaire 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:
Strongly disagree
Disagree
Neutral
Agree
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.
within 24 hours of surgery
Secondary Volume (cm3), of Tissue Removed With Specimen With Tag (Not Including Shave Margins, if Taken) Amount of tissue removed with radiofrequency tag. at time of pathologic evaluation of surgical specimen, within 4 weeks of surgery
See also
  Status Clinical Trial Phase
Completed NCT03273426 - Prediction of pCR by Preoperative Biopsy in Breast Cancer With cCR After Neoadjuvant Chemotherapy. N/A
Recruiting NCT04583124 - Adjusting the Dose of Therapeutic Exercise to Prevent Neurotoxicity Due to Anticancer Treatment (ATENTO) N/A
Active, not recruiting NCT04489173 - TAS102 in Patients With ER-positive, HER2-negative Advanced Breast Cancer Phase 2
Recruiting NCT02913573 - Effect of Pectoral Nerve Block on Post-op Pain in Patients Undergoing Mastectomy and Immediate Reconstruction Phase 2
Completed NCT03124095 - Combined Training Intervention for Women Who Underwent Primary Treatment for Breast Cancer N/A
Terminated NCT00251095 - Comparison of Safety and Efficacy of TOCOSOL(R) Paclitaxel Versus Taxol(R) for Treatment of Metastatic Breast Cancer Phase 3
Completed NCT05576545 - Develop and Evaluate the Effectiveness of a Self-Care Smartphone Application on the Self-Efficacy, and Resilience Among Newly Diagnosed Breast Cancer Patients Undergoing Treatment N/A
Active, not recruiting NCT03625635 - Effect of a Clinical Nutrition Intervention Program in Breast Cancer Patients During Antineoplastic Treatment N/A
Recruiting NCT04799535 - Quantitative Microvasculature Imaging for Breast Cancer Detection and Monitoring
Withdrawn NCT03266562 - Estrogen Receptor Expression in Breast Cancer - Assessed With Positron Emission Mammography N/A
Completed NCT00530868 - Comparing Letrozole Given Alone to Letrozole Given With Avastin in Post-Menopausal Women Breast Cancer Phase 2
Recruiting NCT06255808 - Development of Assist Tool for Breast Examination Using the Principle of Ultrasonic Sensor
Completed NCT04640220 - Improvement of Range of Motion in Frozen Shoulder in Breast Cancer Survivors N/A
Completed NCT02970682 - SFX-01 in the Treatment and Evaluation of Metastatic Breast Cancer Phase 2
Completed NCT02316561 - Single Dose Ablative Radiation Treatment for Early-Stage Breast Cancer N/A
Terminated NCT00638963 - Temozolomide as a Prophylaxis Against Brain Recurrence in Participants With Metastatic Breast Cancer (P05225 AM2) Phase 2
Terminated NCT00249301 - A Study of MLN8054 in Patients With Advanced Solid Tumors Phase 1
Not yet recruiting NCT06056414 - Study of Anxiety After a Session of Energy Resonance by Cutaneous Stimulation N/A
Recruiting NCT05427071 - Magnetic Marker Localization for Occult Breast Cancer and Target Axillary Dissection in Node-positive Breast Cancer Post-neoadjuvant Chemotherapy N/A
Recruiting NCT03740893 - PHOENIX DDR/Anti-PD-L1 Trial: A Pre-surgical Window of Opportunity and Post-surgical Adjuvant Biomarker Study of DNA Damage Response Inhibition and/or Anti-PD-L1 Immunotherapy in Patients With Neoadjuvant Chemotherapy Resistant Residual Triple Negative Breast Cancer Phase 2