Breast NeoplasmNCT02432118
Radiofrequency-Guided Localization in Patients With Abnormal Breast Tissue Undergoing Lumpectomy
A study testing Lumpectomy, Questionnaire Administration and Radiofrequency-Guided Localization in people with Breast Neoplasm, run by Stanford University.
Trial summary
This pilot clinical trial studies the use of the radiofrequency-guided localization in patients with abnormal breast tissue undergoing lumpectomy (a type of breast-sparing surgery). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Neoplasm
- What is being tested?
- Lumpectomy, Questionnaire Administration and Radiofrequency-Guided Localization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2015to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have had stereotactic or ultrasound-guided biopsy with marker placement
- Have a lesion or biopsy marker that is visible under ultrasound
- Have a surgical target =< 6 cm from the skin when lying supine
- Have a discreet surgical target
- Have a lesion in which the center/focal area is defined
- Have the ability to understand and the willingness to sign a written informed consent document
- Eastern Cooperative Oncology Group (ECOG)/Karnofsky performance status will not be used as an inclusion criterion
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Require more than one localization needle for localization of the surgical target (bracket localization)
- Have undergone previous open surgical biopsy, lumpectomy, or mastectomy in the operative breast
- Have a prosthesis/implant in the operative breast
- Have a cardiac pacemaker or defibrillator device
- Be contraindicated for surgery
- Be pregnant
About this study
Official title: A Feasibility Study of Radiofrequency Identification (RFID) Localization of Breast Lesions
This pilot clinical trial studies the use of the radiofrequency-guided localization in patients with abnormal breast tissue undergoing lumpectomy (a type of breast-sparing surgery). The radiofrequency identification localization system consists of an implantable radiofrequency identification tag and a hand-held radiofrequency reader to mark abnormal breast tissue before surgery and later surgically retrieve them. Radiofrequency-guided localization may make it easier to find and remove abnormal breast tissue during lumpectomy.
Read the detailed description
PRIMARY OBJECTIVES:
- To obtain human clinical data in order to demonstrate that the Radiofrequency Identification (RFID) Localization System performs as intended as a localization device for marking and retrieving a surgical target in the breast.
SECONDARY OBJECTIVES:
- To solicit feedback from the radiologists and surgeons regarding the process and use of the RFID system.
OUTLINE:
Patients undergo radiofrequency-guided localization comprising RFID tag placement before lumpectomy and interactive detection of tag using RFID reader during lumpectomy.
- Conditions
- Breast Neoplasm
- Being tested
- Lumpectomy, Questionnaire Administration, Radiofrequency-Guided Localization
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LumpectomyProcedure or surgery
Also called Lumpectomy of Breast, partial mastectomy
Undergo lumpectomy
Questionnaire AdministrationOther
Ancillary studies
Radiofrequency-Guided LocalizationProcedure or surgery
Undergo radiofrequency-guided localization
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (radiofrequency-guided localization) | Experimental | Patients undergo radiofrequency-guided localization comprising RFID tag placement before lumpectomy and interactive detection of tag using RFID reader during lumpectomy. Receives: Procedure: Lumpectomy; Other: Questionnaire Administration; Procedure: Radiofrequency-Guided Localization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Localization success, defined as the surgical target visualized in the removed specimen AND the RFID tag removed from the patient's breast
Will be summarized using descriptive statistics, including total numbers, percentages, means, and proportions.
Measured: At time of surgery
Secondary outcomes (1)
Feedback solicited from the radiologist and surgeon
Feedback solicited from the radiologist and surgeon will be summarized using qualitative methods. Each questionnaire will be reviewed for both positive and negative responses and summarized.
Measured: Up to 12 months after lumpectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2015 (estimated)
- Study startMay 2015
- Primary completionFeb 2016 (estimated)
- Study completionMay 2016 (estimated)
Why it stopped: Insufficient resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jafi Lipson, Principal investigator, Stanford University Hospitals and Clinics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02432118
- Sponsor's protocol ID
- BRS0053
- Other IDs
- NCI-2015-00630, 348, BRS0053, P30CA124435
- Status last verified
- Jan 2017
- First submitted
- 28 Apr 2015
- Last updated
- 2 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of Radiofrequency Identification (RFID) Localization of Breast Lesions
- ClinicalTrials.gov ID
- NCT02432118
- Acronym / sponsor ID
- BRS0053
- Conditions
- Breast Neoplasm
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Insufficient resources
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2015
- Primary completion
- Feb 2016 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 1 May 2015 (estimated)
- Results
- Not posted in the source record
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 the use of the radiofrequency-guided localization in patients with abnormal breast tissue undergoing lumpectomy (a type of breast-sparing surgery). The radiofrequency identification localization system consists of an implantable radiofrequency identification tag and a hand-held radiofrequency reader to mark abnormal breast tissue before surgery and later surgically retrieve them. Radiofrequency-guided localization may make it easier to find and remove abnormal breast tissue during lumpectomy.
Detailed description
PRIMARY OBJECTIVES:
- To obtain human clinical data in order to demonstrate that the Radiofrequency Identification (RFID) Localization System performs as intended as a localization device for marking and retrieving a surgical target in the breast.
SECONDARY OBJECTIVES:
- To solicit feedback from the radiologists and surgeons regarding the process and use of the RFID system.
OUTLINE:
Patients undergo radiofrequency-guided localization comprising RFID tag placement before lumpectomy and interactive detection of tag using RFID reader during lumpectomy.
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 | Procedure: Lumpectomy, Other: Questionnaire Administration, Procedure: Radiofrequency-Guided LocalizationPatients undergo radiofrequency-guided localization comprising RFID tag placement before lumpectomy and interactive detection of tag using RFID reader during lumpectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Have had stereotactic or ultrasound-guided biopsy with marker placement
- Have a lesion or biopsy marker that is visible under ultrasound
- Have a surgical target =< 6 cm from the skin when lying supine
- Have a discreet surgical target
- Have a lesion in which the center/focal area is defined
Key exclusion criteria (6 listed)
- Require more than one localization needle for localization of the surgical target (bracket localization)
- Have undergone previous open surgical biopsy, lumpectomy, or mastectomy in the operative breast
- Have a prosthesis/implant in the operative breast
- Have a cardiac pacemaker or defibrillator device
- Be contraindicated for surgery
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 |
|---|---|---|
| LumpectomyAlso: Lumpectomy of Breast, partial mastectomyUndergo lumpectomy | Procedure or surgery | Diagnostic (radiofrequency-guided localization) |
| Questionnaire AdministrationAncillary studies | Other | Diagnostic (radiofrequency-guided localization) |
| Radiofrequency-Guided LocalizationUndergo radiofrequency-guided localization | Procedure or surgery | Diagnostic (radiofrequency-guided localization) |
Primary outcome
Localization success, defined as the surgical target visualized in the removed specimen AND the RFID tag removed from the patient's breast
Time frame: At time of surgery
Will be summarized using descriptive statistics, including total numbers, percentages, means, and proportions.
1 secondary outcome
Feedback solicited from the radiologist and surgeon
Time frame: Up to 12 months after lumpectomy
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2017.
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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.
Jafi Lipson principal investigator
Stanford University Hospitals and Clinics
Questions about this trial
What is this clinical trial studying?
A study testing Lumpectomy, Questionnaire Administration and Radiofrequency-Guided Localization in people with Breast Neoplasm, run by Stanford University.
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 8 inclusion and 6 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: withdrawn, as of the sponsor's last update on 2 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Localization success, defined as the surgical target visualized in the removed specimen AND the RFID tag removed from the patient's breast (time frame: At time of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Feb 2017.