Breast NeoplasmNCT03202472
Radiofrequency Identification Technology in Locating Non-palpable Breast Lesions in Patients Undergoing Surgery
A study testing Implanted Medical Device, Mammography and Questionnaire Administration in people with Breast Neoplasm and Lesion, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Breast Neoplasm, Lesion
- What is being tested?
- Implanted Medical Device, Mammography and Questionnaire Administration
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2017to 1 Feb 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Multicentric breast cancer
- Stage IV breast cancer
- Pregnant or lactating females
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Breast Neoplasm, Lesion
- Being tested
- Implanted Medical Device, Mammography, Questionnaire Administration, Radiofrequency (RFID) -Guided Localization, Ultrasonography
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implanted Medical DeviceDevice
Also called IMPLANTED
Radiofrequency tag
MammographyProcedure or surgery
Undergo mammogram for image-guided placement of radiofrequency tag
Questionnaire AdministrationOther
Ancillary studies
Radiofrequency (RFID) -Guided LocalizationProcedure or surgery
Also called RFID Localization, RFID-Guided Localization
Undergo radiofrequency-guided localization
UltrasonographyProcedure or surgery
Also called 2-Dimensional Grayscale Ultrasound Imaging, 2-Dimensional Ultrasound Imaging, 2D-US, ULTRASOUND
Undergo ultrasound for image-guided placement of radiofrequency tag
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (radiofrequency-guided localization) | Experimental | 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. Receives: Device: Implanted Medical Device; Procedure: Mammography; Other: Questionnaire Administration; Procedure: Radiofrequency (RFID) -Guided Localization; Procedure: Ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients With Successful Placement of the Radiofrequency Tag Under Radiographic Guidance Confirmed by Mammography
Patients with successful radiofrequency tag placement
Measured: at time of device placement, confirmed by mammography
Patients With Successful Retrieval of the Radiofrequency Tag Confirmed by Specimen Radiography
Patients with successful radiofrequency tag retrieval.
Measured: at time of surgery, within 30 days of tag implant
Secondary outcomes (8)
Days Prior to Surgery of Insertion of Marker
Mean number of days before surgery that radiofrequency tag was placed.
Measured: Up to 30 days prior to surgery
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.
Measured: within 24 hours of device placement
Patients With Cancer Requiring Re-excision
Patients requiring re-excision.
Measured: up to 4 weeks post initial surgery
Patients With Documented Migration of Marker
Movement of radiofrequency tag from point of placement
Measured: at time of surgery, within 30 days of tag implant
Patients With Positive Margins on Initial Lumpectomy Using Radiofrequency Identification Technology
Patients with margins of excisable tissue remaining.
Measured: at time of pathologic evaluation of surgical specimen, within 4 weeks of surgery
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.
Measured: within 24 hours of device placement
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.
Measured: within 24 hours of surgery
Volume (cm3), of Tissue Removed With Specimen With Tag (Not Including Shave Margins, if Taken)
Amount of tissue removed with radiofrequency tag.
Measured: at time of pathologic evaluation of surgical specimen, within 4 weeks of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study start3 Aug 2017
- Primary completion12 Jan 2018
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Maggie DiNome, MD, Principal investigator, UCLA / Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03202472
- Sponsor's protocol ID
- 17-000668
- Other IDs
- NCI-2017-01097, UCLA LOCalizer 00 I, 17-000668
- Status last verified
- Jun 2020
- First submitted
- 26 Jun 2017
- Last updated
- 24 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
DiNome ML, Kusske AM, Attai DJ, Fischer CP, Hoyt AC. Microchipping the breast: an effective new technology for localizing non-palpable breast lesions for surgery. Breast Cancer Res Treat. 2019 May;175(1):165-170. doi: 10.1007/s10549-019-05143-w. Epub 2019 Jan 28.
PubMed 30689105
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial Evaluating a Miniature Radiofrequency Tag for Localization of Non-palpable Breast Lesions for Surgery
- ClinicalTrials.gov ID
- NCT03202472
- Acronym / sponsor ID
- 17-000668
- Conditions
- Breast Neoplasm, Lesion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 3 Aug 2017 (actual)
- Primary completion
- 12 Jan 2018 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 28 Jun 2017 (actual)
- Results
- Posted 7 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (radiofrequency-guided localization) | Experimental | Device: Implanted Medical Device, Procedure: Mammography, Other: Questionnaire Administration, Procedure: Radiofrequency (RFID) -Guided Localization, Procedure: UltrasonographyPatients 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Multicentric breast cancer
- Stage IV breast cancer
- Pregnant or lactating females
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implanted Medical DeviceAlso: IMPLANTEDRadiofrequency tag | Device | Diagnostic (radiofrequency-guided localization) |
| MammographyUndergo mammogram for image-guided placement of radiofrequency tag | Procedure or surgery | Diagnostic (radiofrequency-guided localization) |
| Questionnaire AdministrationAncillary studies | Other | Diagnostic (radiofrequency-guided localization) |
| Radiofrequency (RFID) -Guided LocalizationAlso: RFID Localization, RFID-Guided LocalizationUndergo radiofrequency-guided localization | Procedure or surgery | Diagnostic (radiofrequency-guided localization) |
| UltrasonographyAlso: 2-Dimensional Grayscale Ultrasound Imaging, 2-Dimensional Ultrasound Imaging, 2D-US, ULTRASOUNDUndergo ultrasound for image-guided placement of radiofrequency tag | Procedure or surgery | Diagnostic (radiofrequency-guided localization) |
Primary outcome
Patients With Successful Placement of the Radiofrequency Tag Under Radiographic Guidance Confirmed by Mammography
Time frame: 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
Time frame: at time of surgery, within 30 days of tag implant
Patients with successful radiofrequency tag retrieval.
8 secondary outcomes
Days Prior to Surgery of Insertion of Marker
Time frame: Up to 30 days prior to surgery
Patient Experience With Image-guided Placement of Tag as Rated by a Patient Questionnaire
Time frame: within 24 hours of device placement
Patients With Cancer Requiring Re-excision
Time frame: up to 4 weeks post initial surgery
Patients With Documented Migration of Marker
Time frame: at time of surgery, within 30 days of tag implant
Patients With Positive Margins on Initial Lumpectomy Using Radiofrequency Identification Technology
Time frame: at time of pathologic evaluation of surgical specimen, within 4 weeks of surgery
Radiologist's Experience Placing Radiofrequency Tag Compared to Wire Localization as Measured by a Radiologist's Questionnaire
Time frame: within 24 hours of device placement
Surgeon's Experience Using Radiofrequency Tag to Guide Resection Compared to Wire Localization as Measured by a Surgeon's Questionnaire
Time frame: within 24 hours of surgery
Volume (cm3), of Tissue Removed With Specimen With Tag (Not Including Shave Margins, if Taken)
Time frame: at time of pathologic evaluation of surgical specimen, within 4 weeks of surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30689105DiNome ML, Kusske AM, Attai DJ, Fischer CP, Hoyt AC. Microchipping the breast: an effective new technology for localizing non-palpable breast lesions for surgery. Breast Cancer Res Treat. 2019 May;175(1):165-170. doi: 10.1007/s10549-019-05143-w. Epub 2019 Jan 28.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maggie DiNome, MD principal investigator
UCLA / Jonsson Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implanted Medical Device, Mammography and Questionnaire Administration in people with Breast Neoplasm and Lesion, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients With Successful Placement of the Radiofrequency Tag Under Radiographic Guidance Confirmed by Mammography (time frame: at time of device placement, confirmed by mammography). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03202472, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2020.