Breast Neoplasm, Lesion
Conditions
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.
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.
Interventions
DEVICEImplanted Medical Device
Radiofrequency tag
PROCEDUREMammography
Undergo mammogram for image-guided placement of radiofrequency tag
OTHERQuestionnaire Administration
Ancillary studies
PROCEDURERadiofrequency (RFID) -Guided Localization
Undergo radiofrequency-guided localization
PROCEDUREUltrasonography
Undergo ultrasound for image-guided placement of radiofrequency tag
Sponsors
AstraZeneca
Jonsson Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patients With Successful Placement of the Radiofrequency Tag Under Radiographic Guidance Confirmed by Mammography | at time of device placement, confirmed by mammography | Patients with successful radiofrequency tag placement |
| Patients With Successful Retrieval of the Radiofrequency Tag Confirmed by Specimen Radiography | at time of surgery, within 30 days of tag implant | Patients with successful radiofrequency tag retrieval. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patients With Cancer Requiring Re-excision | up to 4 weeks post initial surgery | Patients requiring re-excision. |
| Patients With Documented Migration of Marker | at time of surgery, within 30 days of tag implant | Movement of radiofrequency tag from point of placement |
| Patients With Positive Margins on Initial Lumpectomy Using Radiofrequency Identification Technology | at time of pathologic evaluation of surgical specimen, within 4 weeks of surgery | Patients with margins of excisable tissue remaining. |
| Days Prior to Surgery of Insertion of Marker | Up to 30 days prior to surgery | Mean number of days before surgery that radiofrequency tag was placed. |
| Surgeon's Experience Using Radiofrequency Tag to Guide Resection Compared to Wire Localization as Measured by a Surgeon's Questionnaire | within 24 hours of surgery | 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. |
| Volume (cm3), of Tissue Removed With Specimen With Tag (Not Including Shave Margins, if Taken) | at time of pathologic evaluation of surgical specimen, within 4 weeks of surgery | Amount of tissue removed with radiofrequency tag. |
| Radiologist's Experience Placing Radiofrequency Tag Compared to Wire Localization as Measured by a Radiologist's Questionnaire | within 24 hours of device placement | 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. |
| Patient Experience With Image-guided Placement of Tag as Rated by a Patient Questionnaire | within 24 hours of device placement | 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. |
Countries
United States
Participant flow
Recruitment details
Dates of recruitment period: Patient consent and enrollment began 9-Aug-2017 and the final surgical procedure was performed 12-Jan-2018. Fifty-five patients were accessed for eligibility. Five patients who initially consented for the study but then withdrew prior to intervention because their surgeries were either cancelled or rescheduled
Pre-assignment details
There are no pre- assignment details to describe
Participants by arm
| Arm | Count |
|---|---|
| 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.
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 | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | Diagnostic (Radiofrequency-guided Localization) | — |
|---|---|---|
| Age, Continuous | 60 years | — |
| Imaging Diagnosis Mammogram | 26 Participants | — |
| Imaging Diagnosis Ultrasound | 24 Participants | — |
| Lesion Category Atypical ductal hyperplasia (ADH) | 3 Participants | — |
| Lesion Category DCIS with microinvasion | 1 Participants | — |
| Lesion Category Ductal carcinoma in situ (DCIS) | 5 Participants | — |
| Lesion Category Encapsulated papillary carcinoma | 1 Participants | — |
| Lesion Category Fibroadenoma with atypia | 1 Participants | — |
| Lesion Category Glomus tumor | 1 Participants | — |
| Lesion Category Invasive ductal carcinoma (IDC) | 23 Participants | — |
| Lesion Category Invasive lobular carcinoma (ILC) | 3 Participants | — |
| Lesion Category Lobular neoplasia | 1 Participants | — |
| Lesion Category Papilloma | 3 Participants | — |
| Lesion Category Phyllodes, benign | 1 Participants | — |
| Lesion Category Radial Scar | 5 Participants | — |
| Lesion Category Stromal Fibrosis | 2 Participants | — |
| Lesion Diagnosis Benign | 17 Participants | — |
| Lesion Diagnosis Cancerous | 33 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 50 Participants | — |
| Sex: Female, Male Female | 50 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 50 |
| other Total, other adverse events | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 |
Outcome results
Primary
Patients With Successful Placement of the Radiofrequency Tag Under Radiographic Guidance Confirmed by Mammography
Patients with successful radiofrequency tag placement
Time frame: at time of device placement, confirmed by mammography
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Diagnostic (Radiofrequency-guided Localization) | Patients With Successful Placement of the Radiofrequency Tag Under Radiographic Guidance Confirmed by Mammography | 50 Participants |
Primary
Patients With Successful Retrieval of the Radiofrequency Tag Confirmed by Specimen Radiography
Patients with successful radiofrequency tag retrieval.
Time frame: at time of surgery, within 30 days of tag implant
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Diagnostic (Radiofrequency-guided Localization) | Patients With Successful Retrieval of the Radiofrequency Tag Confirmed by Specimen Radiography | 50 Participants |
Secondary
Days Prior to Surgery of Insertion of Marker
Mean number of days before surgery that radiofrequency tag was placed.
Time frame: Up to 30 days prior to surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diagnostic (Radiofrequency-guided Localization) | Days Prior to Surgery of Insertion of Marker | 1.4 days | Standard Deviation 2.8 |
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: 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.
Time frame: within 24 hours of device placement
Population: All Patients
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diagnostic (Radiofrequency-guided Localization) | Patient Experience With Image-guided Placement of Tag as Rated by a Patient Questionnaire | 21.3 units on a scale | Standard Deviation 3.9 |
Secondary
Patients With Cancer Requiring Re-excision
Patients requiring re-excision.
Time frame: up to 4 weeks post initial surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Diagnostic (Radiofrequency-guided Localization) | Patients With Cancer Requiring Re-excision | 2 Participants |
Secondary
Patients With Documented Migration of Marker
Movement of radiofrequency tag from point of placement
Time frame: at time of surgery, within 30 days of tag implant
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Diagnostic (Radiofrequency-guided Localization) | Patients With Documented Migration of Marker | 0 Participants |
Secondary
Patients With Positive Margins on Initial Lumpectomy Using Radiofrequency Identification Technology
Patients with margins of excisable tissue remaining.
Time frame: at time of pathologic evaluation of surgical specimen, within 4 weeks of surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Diagnostic (Radiofrequency-guided Localization) | Patients With Positive Margins on Initial Lumpectomy Using Radiofrequency Identification Technology | 4 Participants |
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: 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.
Time frame: within 24 hours of device placement
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diagnostic (Radiofrequency-guided Localization) | Radiologist's Experience Placing Radiofrequency Tag Compared to Wire Localization as Measured by a Radiologist's Questionnaire | 20.4 units on a scale | Standard Deviation 2.4 |
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: 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.
Time frame: within 24 hours of surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diagnostic (Radiofrequency-guided Localization) | Surgeon's Experience Using Radiofrequency Tag to Guide Resection Compared to Wire Localization as Measured by a Surgeon's Questionnaire | 21.5 units on a scale | Standard Deviation 2.7 |
Secondary
Volume (cm3), of Tissue Removed With Specimen With Tag (Not Including Shave Margins, if Taken)
Amount of tissue removed with radiofrequency tag.
Time frame: at time of pathologic evaluation of surgical specimen, within 4 weeks of surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diagnostic (Radiofrequency-guided Localization) | Volume (cm3), of Tissue Removed With Specimen With Tag (Not Including Shave Margins, if Taken) | 30.7 CM3 | Standard Deviation 26.4 |