Breast Cancer FemaleNCT04314700
Intraoperative Use of an Optical Coherence Tomography (OCT) Imaging System to Guide Additional Margin Cavity Shaves in Breast Conserving Surgery (BCS)
A study testing OCT- based investigational imaging device in people with Breast Cancer Female, run by Perimeter Medical Imaging at 1 site in United States.
Trial summary
Female patients undergoing a breast conserving procedure will be consented for the excised breast tissue to be imaged on an investigational OCT-based device. Additional tissue may be excised to obtain clear/negative margins based on routine standard of care tissue assessment techniques and intraoperative OCT image… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- OCT- based investigational imaging device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2020to 7 Dec 2021
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female age 18 or older
- Patients undergoing elective breast conservation surgery for the treatment of Stage 0-III invasive ductal or lobular breast carcinoma and/or ductal carcinoma in situ
- May include subjects treated with neo-adjuvant endocrine therapy
- May include subjects treated with neo-adjuvant chemotherapy with confirmed complete clinical response
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Male
- Stage IV breast cancer
- Participation in another study that prolongs time to pathologic processing (greater than 1 hour)
- Neo-adjuvant treated patients with any chemotherapeutic who have not achieved a complete clinical response
- A surgeon makes an intraoperative decision to conduct a frozen section analysis (Any subject-specific data collected from an enrolled subject until the surgeon's intraoperative decision will not be used in the data analysis of this study. These subjects will be replaced in the study and the surgeon's intraoperative decision to conduct a frozen section analysis will be recorded).
- Use of cryosurgery
Show all 9Show fewer
- Currently lactating
- Current pregnancy
- Previous ipsilateral breast surgery for benign or malignant disease in the same quadrant as currently planned surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
Northern Arizona Healthcare
Cottonwood, Arizona, 86326
About this study
Official title: Intraoperative Use of the OTIS™ (OCT Imaging System) to Guide Additional Margin Cavity Shaves in Breast Conserving Surgery (BCS)
Female patients undergoing a breast conserving procedure will be consented for the excised breast tissue to be imaged on an investigational OCT-based device. Additional tissue may be excised to obtain clear/negative margins based on routine standard of care tissue assessment techniques and intraoperative OCT image review.
Read the detailed description
Note: A retrospective review of the stated purpose and objectives of the PER-19-02 protocol has determined that this study better fits the definition of a medical device feasibility study, with regard to FDA guidance "Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies," issued October 2013. The primary objectives of the PER-19-02 study (NCT04314700) emphasize user factors, rather than health outcomes, as the focus is on collecting information related to usability and timing, with no change to the standard of care (pathology analysis and additional surgery when needed). PER-19-02 was not used as a pivotal study to support the substantial equivalence or safety and effectiveness evidence submitted as part of an FDA pre-market submission. The IDE-approved pivotal study for evaluating the effect of Perimeter's OCT technology on health-related outcomes in breast surgery is the randomized control trial registered on ClinicalTrials.gov under protocol PER-19-04 (NCT05113927). Perimeter has determined this trial does not meet the definition of an Applicable Clinical Trial per the "Checklist for Evaluating Whether a Clinical Trial or Study is an Applicable Clinical Trial (ACT) Under 42 CFR 11.22(b) for Clinical Trials Initiated on or After January 18, 2017."
- Conditions
- Breast Cancer Female
- Being tested
- OCT- based investigational imaging device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCT- based investigational imaging deviceDevice
Excised breast lumpectomy tissue will be imaged and images reviewed on an investigational Wide-Field OCT (WF-OCT) device.
| Study group | Role | What they receive |
|---|---|---|
| OCT imaging and review of excised breast lumpectomy tissue | Other | Not described Receives: Device: OCT- based investigational imaging device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of times the surgeon recorded a decision to excise additional tissue based on intra-operative Wide Field Optical Coherence Tomography (WF-OCT) image review in addition to Standard of Care tissue assessment.
Surgeon's assessment of margin status post Wide Field OCT (WF-OCT) image review and any action taken, will be recorded.
Measured: Within 1 hour of tissue excision
Average time to excise additional tissue during Breast Conserving Surgery (BCS)
Time taken to excise additional tissue based on WF-OCT image review, will be recorded.
Measured: Within 1 hour of primary tumor excision
Calculate percentage of patients that require a second surgery
Record percentage of patients with positive margins per pathology, that require a second surgery.
Measured: Within about 3 months of first surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study start11 Feb 2020
- Primary completion31 Oct 2021
- Study completion7 Dec 2021
Why it stopped: PI left the site
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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Perimeter Medical Imaging
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Beth DuPree, MD, Principal investigator, Northern Arizona Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04314700
- Sponsor's protocol ID
- PER-19-02
- Status last verified
- May 2023
- First submitted
- 3 Mar 2020
- Last updated
- 26 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified Individual Participant Data (IPD) may be shared with other researchers and the sponsor for research/product development purposes.
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Use of the OTIS™ (OCT Imaging System) to Guide Additional Margin Cavity Shaves in Breast Conserving Surgery (BCS)
- ClinicalTrials.gov ID
- NCT04314700
- Acronym / sponsor ID
- PER-19-02
- Conditions
- Breast Cancer Female
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI left the site
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Perimeter Medical ImagingIndustry (pharma, biotech, devices)
- Study start
- 11 Feb 2020 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 7 Dec 2021 (actual)
- First posted
- 19 Mar 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.
Female patients undergoing a breast conserving procedure will be consented for the excised breast tissue to be imaged on an investigational OCT-based device. Additional tissue may be excised to obtain clear/negative margins based on routine standard of care tissue assessment techniques and intraoperative OCT image review.
Detailed description
Note: A retrospective review of the stated purpose and objectives of the PER-19-02 protocol has determined that this study better fits the definition of a medical device feasibility study, with regard to FDA guidance "Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies," issued October 2013. The primary objectives of the PER-19-02 study (NCT04314700) emphasize user factors, rather than health outcomes, as the focus is on collecting information related to usability and timing, with no change to the standard of care (pathology analysis and additional surgery when needed). PER-19-02 was not used as a pivotal study to support the substantial equivalence or safety and effectiveness evidence submitted as part of an FDA pre-market submission. The IDE-approved pivotal study for evaluating the effect of Perimeter's OCT technology on health-related outcomes in breast surgery is the randomized control trial registered on ClinicalTrials.gov under protocol PER-19-04 (NCT05113927). Perimeter has determined this trial does not meet the definition of an Applicable Clinical Trial per the "Checklist for Evaluating Whether a Clinical Trial or Study is an Applicable Clinical Trial (ACT) Under 42 CFR 11.22(b) for Clinical Trials Initiated on or After January 18, 2017."
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OCT imaging and review of excised breast lumpectomy tissue | Other | Device: OCT- based investigational imaging device |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female age 18 or older
- Patients undergoing elective breast conservation surgery for the treatment of Stage 0-III invasive ductal or lobular breast carcinoma and/or ductal carcinoma in situ
- May include subjects treated with neo-adjuvant endocrine therapy
- May include subjects treated with neo-adjuvant chemotherapy with confirmed complete clinical response
- Ability to understand and the willingness to sign a written informed consent document
Key exclusion criteria (9 listed)
- Male
- Stage IV breast cancer
- Participation in another study that prolongs time to pathologic processing (greater than 1 hour)
- Neo-adjuvant treated patients with any chemotherapeutic who have not achieved a complete clinical response
- A surgeon makes an intraoperative decision to conduct a frozen section analysis (Any subject-specific data collected from an enrolled subject until the surgeon's intraoperative decision will not be used in the data analysis of this study. These subjects will be replaced in the study and the surgeon's intraoperative decision to conduct a frozen section analysis will be recorded).
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 |
|---|---|---|
| OCT- based investigational imaging deviceExcised breast lumpectomy tissue will be imaged and images reviewed on an investigational Wide-Field OCT (WF-OCT) device. | Device | OCT imaging and review of excised breast lumpectomy tissue |
Primary outcome
Number of times the surgeon recorded a decision to excise additional tissue based on intra-operative Wide Field Optical Coherence Tomography (WF-OCT) image review in addition to Standard of Care tissue assessment.
Time frame: Within 1 hour of tissue excision
Surgeon's assessment of margin status post Wide Field OCT (WF-OCT) image review and any action taken, will be recorded.
Average time to excise additional tissue during Breast Conserving Surgery (BCS)
Time frame: Within 1 hour of primary tumor excision
Time taken to excise additional tissue based on WF-OCT image review, will be recorded.
Calculate percentage of patients that require a second surgery
Time frame: Within about 3 months of first surgery
Record percentage of patients with positive margins per pathology, that require a second surgery.
Results and safety
The study was stopped early (reason given: PI left the site). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2023.
- Individual participant dataSharing planned: Yes. De-identified Individual Participant Data (IPD) may be shared with other researchers and the sponsor for research/product development purposes.
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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.
Beth DuPree, MD principal investigator
Northern Arizona Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OCT- based investigational imaging device in people with Breast Cancer Female, run by Perimeter Medical Imaging 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 5 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: stopped early, as of the sponsor's last update on 26 May 2023. 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 was stopped early (reason given: PI left the site). 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?
Number of times the surgeon recorded a decision to excise additional tissue based on intra-operative Wide Field Optical Coherence Tomography (WF-OCT) image review in addition to Standard of Care tissue assessment. (time frame: Within 1 hour of tissue excision). The study lists 3 primary outcomes in all. 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 26 May 2023.