Breast CancerEarly Phase 1NCT02207179
Breast Cancer Margin Delineation Using Polarization Subtraction Imaging Technology
A Early Phase 1 study testing LumaScan Image Guided Surgery in people with Breast Cancer, run by LumaMed at 1 site in United States.
Trial summary
This study will evaluate LumaScan, an innovative polarization microscope for real time, intraoperative imaging and evaluation of the surface of excised tissue excised during Breast Conservation Surgery (BCS) for non invasive and invasive breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- LumaScan Image Guided Surgery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Nov 2015
- Phase
- Early Phase 1
- 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women referred for breast conservation surgery following a diagnosis of invasive or in situ carcinoma of the breast by histopathology or women referred for lumpectomy due to a benign (fibroadenoma or papilloma) or high risk breast lesion(Atypical ductal hyperplasia, atypical lobular hyperplasia, lobular carcinoma in-situ, atypical papilloma).
- 18 years of age or older.
- Able to read or understand and give informed consent.
Who cannot join
- Patients undergoing neo-adjuvant systemic therapy.
- Previous breast cancer and /or radiation in the operated breast.
- Implants in the operated breast.
- Pregnant or Lactating.
- History of photosensitizing disease (porphyria, lupus etc.) or of allergy to methylene blue dye.
- Recent use of photosensitizing agents such as fluoroquinolones and retinoids or patients undergoing phototherapy.
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- Participation in any other intraoperative margin assessment protocol that would affect data acquisition.
- Subareolar location (cancer is directly and completely under the nipple/areolar complex) of breast abnormality.
- Patients for whom English is not their native language
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Wisconsin
Madison, Wisconsin, 53792
Jennifer Mirrielees, MS, 608-265-1113, mirrielees@surgery.wisc.edu
About this study
Official title: Breast Cancer Margin Delineation Using Polarization Subtraction Imaging Technology: An Ex-vivo Pilot Study of Real-time Breast Margin Imaging in Women Undergoing Breast Conservation Surgery for Early Stage Breast Cancer
This study will evaluate LumaScan, an innovative polarization microscope for real time, intraoperative imaging and evaluation of the surface of excised tissue excised during Breast Conservation Surgery (BCS) for non invasive and invasive breast cancer. The investigators hypothesis is that LumaScan will be comparable for cancer detection to conventional histopathologic evaluation of the same areas of breast tissue. The real time, intraoperative images provided by LumaScan will help improve BCS and lessen the need for BCS re-excision surgeries which can lead to higher cost, poor cosmetic outcomes, reduced survival rates, and loss of confidence in the tissue conservation surgery procedure.
Read the detailed description
LumaScan is an innovative polarization microscope that uses Polarization Subtraction Imaging (PSI) technology to provide real time, intra operative, digital images of the surface of tissue removed during BCS for breast cancer. PSI uses polarized visible light for optical sectioning and geometric imaging of the superficial layers of the surgically removed tissue while rejecting surface scatter and light from deeper layers. By rejecting light from deeper tissues PSI is able to exclusively focus on the superficial tissue layers. This also results in higher resolution images than are possible with standard optical imaging. PSI is used in both reflectance and fluorescence modes. Reflectance detects morphologic abnormalities that occur in tumor progression such as increased nuclear density, angiogenesis, cellular infiltration and crowding while fluorescence detects early biochemical changes.
To enhance the contrast of tumor at the margins the investigators will use Methylene blue (MB), a dye that has been commonly used in breast surgery for mapping sentinel lymph nodes. MB can be administered peritumorally and is quickly taken up by cells in only a few minutes of exposure and its presence does not interfere with or preclude later histopathology on the same tissue specimen. A tumor specimen may also be dipped in MB post-excision to achieve tumor margin contrast enhancement and not interfere with pathologic assessment.
Previous research using PSI technology has demonstrated the value of PSI in mapping tumor boundaries of breast cancer in excised tissue specimens and in non-melanoma skin cancers and these boundaries in side by side comparisons correlate well with those marked by a pathologist on representative sections prepared using standard H\&E staining procedures.
- Conditions
- Breast Cancer
- Being tested
- LumaScan Image Guided Surgery
- Keywords
- Intraoperative, Cancer margin, Spectroscopy, Polarization
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LumaScan Image Guided SurgeryDevice
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | No intervention | LumaScan Image Guided Surgery Receives: Device: LumaScan Image Guided Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor areas shown on LumaScan images are the same as those shown on subsequent en-face pathology images.
Quantitative metrics (e.g. size or area of tumor found between the two images) will be used to to compare en-face pathology and corresponding LumaScan images from excised breast tissue margins.
Measured: From day of surgery until receipt of pathology results (upto 2 weeks)
Secondary outcomes (3)
Pathologist interpretation of LumaScan images (blinded) are similar to those of histopathology images.
The Pathologists will be asked to interpret LumaScan images and corresponding histopathology images. The images will be randomly presented to the Pathologist in order to be blinded to each.
Measured: From day of surgery until receipt of pathology results (upto 2 weeks)
Surgeons interpretation of LumaScan images (blinded) are similar to those of histopathology images.
To correlate and determine the surgeons blinded interpretation of the LumaScan images, digital photographs vs. the final pathologic outcomes (post image acquisition)
Measured: From day of surgery until receipt of pathology results (upto 2 weeks)
Time for each margin and bi-valved image acquisition in the operating room
Measured: Duration of surgery (upto 3 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2014 (estimated)
- Study startJan 2014
- Primary completionSep 2015 (estimated)
- Study completionNov 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LumaMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Wisconsin, Madison
- Responsible party
- Sponsor
- Investigators
- Lee G Wilke, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02207179
- Sponsor's protocol ID
- LM010
- Status last verified
- Mar 2015
- First submitted
- 25 Mar 2014
- Last updated
- 31 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Cancer Margin Delineation Using Polarization Subtraction Imaging Technology: An Ex-vivo Pilot Study of Real-time Breast Margin Imaging in Women Undergoing Breast Conservation Surgery for Early Stage Breast Cancer
- ClinicalTrials.gov ID
- NCT02207179
- Acronym / sponsor ID
- LM010
- Conditions
- Breast Cancer
- Keywords
- Intraoperative, Cancer margin, Spectroscopy, Polarization
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- LumaMedIndustry (pharma, biotech, devices)
- Collaborators
- University of Wisconsin, Madison
- Study start
- Jan 2014
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Nov 2015 (estimated)
- First posted
- 4 Aug 2014 (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 study will evaluate LumaScan, an innovative polarization microscope for real time, intraoperative imaging and evaluation of the surface of excised tissue excised during Breast Conservation Surgery (BCS) for non invasive and invasive breast cancer. The investigators hypothesis is that LumaScan will be comparable for cancer detection to conventional histopathologic evaluation of the same areas of breast tissue. The real time, intraoperative images provided by LumaScan will help improve BCS and lessen the need for BCS re-excision surgeries which can lead to higher cost, poor cosmetic outcomes, reduced survival rates, and loss of confidence in the tissue conservation surgery procedure.
Detailed description
LumaScan is an innovative polarization microscope that uses Polarization Subtraction Imaging (PSI) technology to provide real time, intra operative, digital images of the surface of tissue removed during BCS for breast cancer. PSI uses polarized visible light for optical sectioning and geometric imaging of the superficial layers of the surgically removed tissue while rejecting surface scatter and light from deeper layers. By rejecting light from deeper tissues PSI is able to exclusively focus on the superficial tissue layers. This also results in higher resolution images than are possible with standard optical imaging. PSI is used in both reflectance and fluorescence modes. Reflectance detects morphologic abnormalities that occur in tumor progression such as increased nuclear density, angiogenesis, cellular infiltration and crowding while fluorescence detects early biochemical changes.
To enhance the contrast of tumor at the margins the investigators will use Methylene blue (MB), a dye that has been commonly used in breast surgery for mapping sentinel lymph nodes. MB can be administered peritumorally and is quickly taken up by cells in only a few minutes of exposure and its presence does not interfere with or preclude later histopathology on the same tissue specimen. A tumor specimen may also be dipped in MB post-excision to achieve tumor margin contrast enhancement and not interfere with pathologic assessment.
Previous research using PSI technology has demonstrated the value of PSI in mapping tumor boundaries of breast cancer in excised tissue specimens and in non-melanoma skin cancers and these boundaries in side by side comparisons correlate well with those marked by a pathologist on representative sections prepared using standard H\&E staining procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | No intervention | Device: LumaScan Image Guided SurgeryLumaScan Image Guided Surgery |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women referred for breast conservation surgery following a diagnosis of invasive or in situ carcinoma of the breast by histopathology or women referred for lumpectomy due to a benign (fibroadenoma or papilloma) or high risk breast lesion(Atypical ductal hyperplasia, atypical lobular hyperplasia, lobular carcinoma in-situ, atypical papilloma).
- 18 years of age or older.
- Able to read or understand and give informed consent.
Key exclusion criteria (9 listed)
- Patients undergoing neo-adjuvant systemic therapy.
- Previous breast cancer and /or radiation in the operated breast.
- Implants in the operated breast.
- Pregnant or Lactating.
- History of photosensitizing disease (porphyria, lupus etc.) or of allergy to methylene blue dye.
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 |
|---|---|---|
| LumaScan Image Guided Surgery | Device | Single Arm |
Primary outcome
Tumor areas shown on LumaScan images are the same as those shown on subsequent en-face pathology images.
Time frame: From day of surgery until receipt of pathology results (upto 2 weeks)
Quantitative metrics (e.g. size or area of tumor found between the two images) will be used to to compare en-face pathology and corresponding LumaScan images from excised breast tissue margins.
3 secondary outcomes
Pathologist interpretation of LumaScan images (blinded) are similar to those of histopathology images.
Time frame: From day of surgery until receipt of pathology results (upto 2 weeks)
Surgeons interpretation of LumaScan images (blinded) are similar to those of histopathology images.
Time frame: From day of surgery until receipt of pathology results (upto 2 weeks)
Time for each margin and bi-valved image acquisition in the operating room
Time frame: Duration of surgery (upto 3 hours)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2015.
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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.
Lee G Wilke, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing LumaScan Image Guided Surgery in people with Breast Cancer, run by LumaMed 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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 31 Mar 2015. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shabbir B Bambot, PhD (678-907-4711, sbambot@lumamed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor areas shown on LumaScan images are the same as those shown on subsequent en-face pathology images. (time frame: From day of surgery until receipt of pathology results (upto 2 weeks)). 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 31 Mar 2015.