OncologyNCT04683120
Real-time Diagnosis and Visualization of Tumor Margins in Excised Breast Specimens Using Zenith FLIM Diagnostics
A study testing Zenith FLIM Diagnostics in people with Oncology and Breast Cancer, run by Laser LabCorp at 1 site in United States.
Trial summary
Our investigational team has developed a technology to visualize the operative margins in 'real time,' in other words during the operation while the patient is still on the table. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Oncology, Breast Cancer, Cancer Diagnosis
- What is being tested?
- Zenith FLIM Diagnostics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2021to 2 Nov 2022
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A) Age18 and over
- B) EnglishSpeaking
- C) Able to read and understand consent
- D) All patient's candidate for lumpectomy
- E) Recurrent cancer patients requiring lumpectomy
- F) All stages and grades of cancer as long as patient is lumpectomy candidate
Show all 17Show fewer
- G) Margin1(S)
- H) Margin 2(I)
- I) Margin 3 (M)
- J) Margin 4 (L)
- K) Margin5(P)
- L) Margin 6 (A)
- Exclusion Criteria: Exclusion criteria includes any patients with autoimmune disease affecting breast tissue anyone receiving neoadjuvant chemotherapy prior to lumpectomy, any patient undergoing mastectomy.
- A) Extensively damaged tissue
- B) Abnormal tissue(auto immune disease)
- C) Neoadjuvant treated breast
- D) Mastectomy
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Our investigational team has developed a technology to visualize the operative margins in 'real time,' in other words during the operation while the patient is still on the table. While different surgeons use different operative techniques, our technique involves removing the main lumpectomy specimen, marking two of its borders with suture to orient the specimen for correct pathologic evaluation.
The FLIM (Fluorescent Lifetime Imaging Microscopy) technique can differentiate between cancerous and noncancerous specimens using a complex algorithm that essentially utilizes a definitive delta between the metabolic activities of diseased and non-diseased tissue. The research coordinator along with the surgeon will be able to insert the lumpectomy specimen followed by the 6 shaved margins (one by one) in a matter of minutes once the specimens have been resected. To be clear, the FLIM analysis will be taking place in- vitro. The device is invitro test and would be tested against the gold standard the pathologist biopsy.
FLIM analysis by the surgeon will not take more than several minutes, therefore not adding any significant time for patient to be under anesthesia. All specimens will be removed from the patient's body prior to their evaluation by the FLIM technique. Our team will not be making decisions based on FLIM analysis during this early phase of study. In other words, even if FLIM suggests a positive margin still exists in the body, our team will not act on these results by resecting additional tissue at this stage. FLIM margin results will be compared directly with pathology results for accuracy of the findings.
Read the detailed description
The purpose of this study is to evaluate the effectiveness of the investigational Zenith FLIM Diagnostics imaging device that's modality is a direct support during lumpectomy cancer surgery to achieve the common goal of improving patient quality of life by decreasing rates of re-operation. The team is fully dedicated to bringing the Gold Standard in the operating room, enabling margin assessment, in real time, at the histological detail.
Our operative technique involves removing the main lumpectomy specimen, marking two of its borders with suture to orient the specimen for correct pathologic evaluation. Next, we take 6 shave margins in all directions around the lumpectomy cavity (superior, inferior, medial, lateral, posterior, anterior) and anchor an orientation stitch at the far side of the margin, again, for pathologist to understand which side was farthest away from the lumpectomy specimen.
The research coordinator along with the surgeon will be able to insert the lumpectomy specimen into the Zenith FLIM device followed by the 6 shaved margins (one by one) in a matter of minutes once the specimens have been resected. To be clear, the Zenith FLIM analysis will be taking place in-vitro. The machine will be placed a good distance from the patient, in an ante-room, and does not require sterility. Of course, if the surgeon breaks sterility while handing off the specimens for FLIM analysis, he or she will have to re-sterilize as would be standard if sterile conditions are broken for any other reasons (having to re-scrub because sterility is broken is a common procedure). Once the specimens are placed in the Zenith FLIM, the specimens will no longer be sterile, but there is no need to maintain sterility of the specimens once they are in-vitro. In fact, even in the absence of Zenith FLIM analysis, once the specimens are placed in cups for pathologic evaluation, they are no longer sterile. In other words, loss of sterility of the specimen is a necessity of the operation regardless of Zenith FLIM analysis.
The device is an in-vitro test and would be tested against the gold standard: the pathologic evaluation of resected tissue. The test results would not be used for any diagnosis. Neither the test nor the unit comes in contact with patients under any circumstance. The Zenith FLIM margin results will be compared directly with pathology. The effectiveness of the Zenith FLIM Diagnostics margin results will be compared directly with pathology and evaluated in this study.
- Being tested
- Zenith FLIM Diagnostics
- Keywords
- Oncology, Breast Cancer, Zenith FLIM Diagnostics, FLIM, Tumor, Margin Assessment
- Medical subject headings
- Neoplasms, Breast Neoplasms, Margins of Excision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zenith FLIM DiagnosticsDiagnostic test
In-vitro
| Study group | Role | What they receive |
|---|---|---|
| Single Arm Study | Experimental | This is a single arm study, which will involve all patients qualifying for Breast Conservation Therapy as a part of their breast cancer management excluding patients undergoing neoadjuvant therapy for inoperable disease. Receives: Diagnostic Test: Zenith FLIM Diagnostics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor Distance From Margins in all 6 Dimensions
Tumor distance from margin in all 6 dimensions compared to final histopathologic diagnosis/confirmation in testing for accuracy of the Zenith FLIM.
Measured: 5-10 minutes after tumor and margins are extricated from body
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start15 Dec 2021 (estimated)
- Primary completion3 Aug 2022 (estimated)
- Study completion2 Nov 2022 (estimated)
Why it stopped: New Medical Team and Surgical Center Location
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OncologyStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laser LabCorp
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brad Schoengood, Study chair, Laser LabCorp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04683120
- Sponsor's protocol ID
- Laser LabCorp #001
- Status last verified
- Jun 2021
- First submitted
- 19 Dec 2020
- Last updated
- 30 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-time Diagnosis and Visualization of Tumor Margins in Excised Breast Specimens Using Zenith FLIM Diagnostics
- ClinicalTrials.gov ID
- NCT04683120
- Acronym / sponsor ID
- Laser LabCorp #001
- Keywords
- Oncology, Breast Cancer, Zenith FLIM Diagnostics, FLIM, Tumor, Margin Assessment
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: New Medical Team and Surgical Center Location
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Laser LabCorpIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2021 (estimated)
- Primary completion
- 3 Aug 2022 (estimated)
- Study completion
- 2 Nov 2022 (estimated)
- First posted
- 24 Dec 2020 (actual)
- 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.
Our investigational team has developed a technology to visualize the operative margins in 'real time,' in other words during the operation while the patient is still on the table. While different surgeons use different operative techniques, our technique involves removing the main lumpectomy specimen, marking two of its borders with suture to orient the specimen for correct pathologic evaluation.
The FLIM (Fluorescent Lifetime Imaging Microscopy) technique can differentiate between cancerous and noncancerous specimens using a complex algorithm that essentially utilizes a definitive delta between the metabolic activities of diseased and non-diseased tissue. The research coordinator along with the surgeon will be able to insert the lumpectomy specimen followed by the 6 shaved margins (one by one) in a matter of minutes once the specimens have been resected. To be clear, the FLIM analysis will be taking place in- vitro. The device is invitro test and would be tested against the gold standard the pathologist biopsy.
FLIM analysis by the surgeon will not take more than several minutes, therefore not adding any significant time for patient to be under anesthesia. All specimens will be removed from the patient's body prior to their evaluation by the FLIM technique. Our team will not be making decisions based on FLIM analysis during this early phase of study. In other words, even if FLIM suggests a positive margin still exists in the body, our team will not act on these results by resecting additional tissue at this stage. FLIM margin results will be compared directly with pathology results for accuracy of the findings.
Detailed description
The purpose of this study is to evaluate the effectiveness of the investigational Zenith FLIM Diagnostics imaging device that's modality is a direct support during lumpectomy cancer surgery to achieve the common goal of improving patient quality of life by decreasing rates of re-operation. The team is fully dedicated to bringing the Gold Standard in the operating room, enabling margin assessment, in real time, at the histological detail.
Our operative technique involves removing the main lumpectomy specimen, marking two of its borders with suture to orient the specimen for correct pathologic evaluation. Next, we take 6 shave margins in all directions around the lumpectomy cavity (superior, inferior, medial, lateral, posterior, anterior) and anchor an orientation stitch at the far side of the margin, again, for pathologist to understand which side was farthest away from the lumpectomy specimen.
The research coordinator along with the surgeon will be able to insert the lumpectomy specimen into the Zenith FLIM device followed by the 6 shaved margins (one by one) in a matter of minutes once the specimens have been resected. To be clear, the Zenith FLIM analysis will be taking place in-vitro. The machine will be placed a good distance from the patient, in an ante-room, and does not require sterility. Of course, if the surgeon breaks sterility while handing off the specimens for FLIM analysis, he or she will have to re-sterilize as would be standard if sterile conditions are broken for any other reasons (having to re-scrub because sterility is broken is a common procedure). Once the specimens are placed in the Zenith FLIM, the specimens will no longer be sterile, but there is no need to maintain sterility of the specimens once they are in-vitro. In fact, even in the absence of Zenith FLIM analysis, once the specimens are placed in cups for pathologic evaluation, they are no longer sterile. In other words, loss of sterility of the specimen is a necessity of the operation regardless of Zenith FLIM analysis.
The device is an in-vitro test and would be tested against the gold standard: the pathologic evaluation of resected tissue. The test results would not be used for any diagnosis. Neither the test nor the unit comes in contact with patients under any circumstance. The Zenith FLIM margin results will be compared directly with pathology. The effectiveness of the Zenith FLIM Diagnostics margin results will be compared directly with pathology and evaluated in this study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm Study | Experimental | Diagnostic Test: Zenith FLIM DiagnosticsThis is a single arm study, which will involve all patients qualifying for Breast Conservation Therapy as a part of their breast cancer management excluding patients undergoing neoadjuvant therapy for inoperable disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- A) Age18 and over
- B) EnglishSpeaking
- C) Able to read and understand consent
- D) All patient's candidate for lumpectomy
- E) Recurrent cancer patients requiring lumpectomy
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Zenith FLIM DiagnosticsIn-vitro | Diagnostic test | Single Arm Study |
Primary outcome
Tumor Distance From Margins in all 6 Dimensions
Time frame: 5-10 minutes after tumor and margins are extricated from body
Tumor distance from margin in all 6 dimensions compared to final histopathologic diagnosis/confirmation in testing for accuracy of the Zenith FLIM.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2021.
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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.
Brad Schoengood study chair
Laser LabCorp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zenith FLIM Diagnostics in people with Oncology and Breast Cancer, run by Laser LabCorp 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 17 inclusion and 0 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: paused, as of the sponsor's last update on 30 Jun 2021. 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?
Results are not available in the source record.
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?
Tumor Distance From Margins in all 6 Dimensions (time frame: 5-10 minutes after tumor and margins are extricated from body). 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 30 Jun 2021.