Breast Cancer FemaleNCT01209182
In Vitro Detection of Tissue Abnormality
A study testing Testing a new device (LS BioPath TOUCH) on excised tissue in people with Breast Cancer Female, run by LS BioPath at 1 site in United States.
Trial summary
Intraoperative ex-vivo use of the ClearEdge Imaging Device in Breast Conserving Surgery to image the excised tissue surgical margins. The study is designed to demonstrate reduction in the need for repeat surgeries after breast conserving surgeries by using the ClearEdge as an adjunct imaging device to the standard of… Read more about this study
- Who is it for?
- Ages 25 to 80 years, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- Testing a new device (LS BioPath TOUCH) on excised tissue
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2010to 9 Jan 2012
- 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 25 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 25-80 who are scheduled for surgical excision of tissue.
Who cannot join
- No prior history of surgery at location of current surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Intraoperative ex-vivo use of the ClearEdge Imaging Device in Breast Conserving Surgery to image the excised tissue surgical margins. The study is designed to demonstrate reduction in the need for repeat surgeries after breast conserving surgeries by using the ClearEdge as an adjunct imaging device to the standard of care.
Read the detailed description
Intraoperative real-time margin assessment of breast conserving surgeries can reduce the need for repeat operations due to cancer involved margins. Repeat operations result in excessive removal of benign tissue, increased risk for infection, slower healing and inferior cosmetic results. In the current standard of care, the status of the margins is determined by pathology only several days after surgery. An intraoperative assessment of the margins enables complete tumor excision in a single surgery.
The proposed randomized controlled study will evaluate the benefits of adding the ClearEdge imaging device to the Standard of Care (SoC) of margins assessment in breast conserving surgeries. The study will assess whether there is an improvement in the detection of cancer involved margins by measuring whether removal at the time of primary surgical treatment can reduce the need for repeat surgeries as compared to the SoC, which does not use the device.
ClearEdge is a CE marked device already been used in several hospitals in the UK. It was used in a prospective single arm and 2 phases clinical study. It was demonstrated that surgeons successfully used the device to identify cancer involved margins and that it can reduce the need for repeat surgeries by meeting the margins depth criteria to require repeat operations. European Journal of Oncology Surgery. 2016; 42 (12): 1834-1840. In addition, the device was clinically evaluated by several hospitals.
- Conditions
- Breast Cancer Female
- Being tested
- Testing a new device (LS BioPath TOUCH) on excised tissue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testing a new device (LS BioPath TOUCH) on excised tissueDevice
Measurements are obtained with test device on excised tissue.
| Study group | Role | What they receive |
|---|---|---|
| Device image reading | Experimental | Tissue images generated by the device are read by surgeons to determine if the tissue area under test has abnormal component or not. When Images generated by the device are read by surgeons as abnormal an additional margin of tissue is removed. The new margin is also imaged by the device to ensure complete tumor excision. Receives: Device: Testing a new device (LS BioPath TOUCH) on excised tissue |
What is being measured
The primary outcome is the main question the study is designed to answer.
•Accuracy of LS BioPath TOUCH device compared to pathology
Assess percentage of FP and FN of test device results compared to pathology results
Measured: 1 week after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2010 (estimated)
- Study start15 Oct 2010
- Primary completion13 Dec 2011
- Study completion9 Jan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 2 phase study: Phase 1 - Validation of safety and accuracy when used ex-vivo to image excised breast surgery specimens Phase 2 - To guide surgeon's decision to re-excise additional margins during primary operation
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- LS BioPath
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Lagios, MD, Principal investigator, St. Mary's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01209182
- Sponsor's protocol ID
- LSB-01
- Status last verified
- Apr 2022
- First submitted
- 21 Sep 2010
- Last updated
- 3 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vitro Detection of Tissue Abnormality
- ClinicalTrials.gov ID
- NCT01209182
- Acronym / sponsor ID
- LSB-01
- Conditions
- Breast Cancer Female
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- LS BioPathIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2010 (actual)
- Primary completion
- 13 Dec 2011 (actual)
- Study completion
- 9 Jan 2012 (actual)
- First posted
- 27 Sep 2010 (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.
Intraoperative ex-vivo use of the ClearEdge Imaging Device in Breast Conserving Surgery to image the excised tissue surgical margins. The study is designed to demonstrate reduction in the need for repeat surgeries after breast conserving surgeries by using the ClearEdge as an adjunct imaging device to the standard of care.
Detailed description
Intraoperative real-time margin assessment of breast conserving surgeries can reduce the need for repeat operations due to cancer involved margins. Repeat operations result in excessive removal of benign tissue, increased risk for infection, slower healing and inferior cosmetic results. In the current standard of care, the status of the margins is determined by pathology only several days after surgery. An intraoperative assessment of the margins enables complete tumor excision in a single surgery.
The proposed randomized controlled study will evaluate the benefits of adding the ClearEdge imaging device to the Standard of Care (SoC) of margins assessment in breast conserving surgeries. The study will assess whether there is an improvement in the detection of cancer involved margins by measuring whether removal at the time of primary surgical treatment can reduce the need for repeat surgeries as compared to the SoC, which does not use the device.
ClearEdge is a CE marked device already been used in several hospitals in the UK. It was used in a prospective single arm and 2 phases clinical study. It was demonstrated that surgeons successfully used the device to identify cancer involved margins and that it can reduce the need for repeat surgeries by meeting the margins depth criteria to require repeat operations. European Journal of Oncology Surgery. 2016; 42 (12): 1834-1840. In addition, the device was clinically evaluated by several hospitals.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 2 phase study: Phase 1 - Validation of safety and accuracy when used ex-vivo to image excised breast surgery specimens Phase 2 - To guide surgeon's decision to re-excise additional margins during primary operation
| Arm | Type | Receives |
|---|---|---|
| Device image reading | Experimental | Device: Testing a new device (LS BioPath TOUCH) on excised tissueTissue images generated by the device are read by surgeons to determine if the tissue area under test has abnormal component or not. When Images generated by the device are read by surgeons as abnormal an additional margin of tissue is removed. The new margin is also imaged by the device to ensure complete tumor excision. |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 25-80 who are scheduled for surgical excision of tissue.
Key exclusion criteria (1 listed)
- No prior history of surgery at location of current 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 |
|---|---|---|
| Testing a new device (LS BioPath TOUCH) on excised tissueMeasurements are obtained with test device on excised tissue. | Device | Device image reading |
Primary outcome
•Accuracy of LS BioPath TOUCH device compared to pathology
Time frame: 1 week after surgery
Assess percentage of FP and FN of test device results compared to pathology results
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2022.
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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.
Michael Lagios, MD principal investigator
St. Mary's Medical 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 Testing a new device (LS BioPath TOUCH) on excised tissue in people with Breast Cancer Female, run by LS BioPath 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 1 inclusion and 1 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 3 Oct 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
•Accuracy of LS BioPath TOUCH device compared to pathology (time frame: 1 week after 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 3 Oct 2022.