Breast CancerNCT02313116
Computed Optical Margin Assessment for Breast Cancer Surgery, Phase I (Part B)
An observational study of Breast Cancer, run by Diagnostic Photonics, Inc. at 1 site in United States.
Trial summary
This intraoperative study is a prospective study analyzing specimens from fifty subjects. Patients scheduled to undergo breast-conserving surgery will be recruited in accordance with the inclusion and exclusion criteria. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Interferometric Synthetic Aperture Microscopy
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to 18 Mar 2020
- Phase
- Observational
- 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
Study population: Women with breast cancer undergoing lumpectomy.
Who may be able to join
- Women 18 years of age or older
- Signed informed consent form
- Women who have been histologically diagnosed with carcinoma of the breast prior to surgery
- Patients planning breast preservation and undergoing lumpectomy (partial mastectomy) procedure
Who cannot join
- Multicentric disease (histologically diagnosed cancer in two different quadrants of the breast)
- Neoadjuvant systemic therapy
- All T4 tumors
- Previous radiation in the operated breast
- Prior surgical procedure in the same quadrant
- Implants in the operated breast
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- Pregnancy
- Lactation
- Participating in any other investigational study for either drug or device which can influence collection of valid data under this study
Trial locations and contacts
1 site in 1 country.
About this study
This intraoperative study is a prospective study analyzing specimens from fifty subjects. Patients scheduled to undergo breast-conserving surgery will be recruited in accordance with the inclusion and exclusion criteria. The study period per subject is the time it takes to assess the ex vivo breast tissue sample using the study device. Image review will be conducted during surgery and compared to the margin status findings in the post-operative pathology report.
- Conditions
- Breast Cancer
- Being tested
- Interferometric Synthetic Aperture Microscopy
- Keywords
- Lumpectomy, Breast cancer, Optical coherence tomography, Tumor margin, Imaging
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferometric Synthetic Aperture MicroscopyDevice
Also called Optical Coherence Tomography
Optical coherence tomography with interferometric synthetic aperture microscopy will be used to image ex vivo breast tissue specimens.
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients With All Positive/Close Margins Correctly Identified With the Device
Measured: 1 week after surgery
Number of Margins With False Positive Device Readings
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 posted9 Dec 2014 (estimated)
- Study startApr 2014
- Primary completionFeb 2020 (estimated)
- Study completion18 Mar 2020 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diagnostic Photonics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lisa Jacobs, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02313116
- Sponsor's protocol ID
- DxP 2012-02 (Part B)
- Status last verified
- Jul 2019
- First submitted
- 5 Dec 2014
- Last updated
- 18 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computed Optical Margin Assessment for Breast Cancer Surgery, Phase I (Part B)
- ClinicalTrials.gov ID
- NCT02313116
- Acronym / sponsor ID
- DxP 2012-02 (Part B)
- Conditions
- Breast Cancer
- Keywords
- Lumpectomy, Breast cancer, Optical coherence tomography, Tumor margin, Imaging
- Study type
- Observational
- Recruitment status
- Suspended
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Diagnostic Photonics, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Feb 2020 (estimated)
- Study completion
- 18 Mar 2020 (estimated)
- First posted
- 9 Dec 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 intraoperative study is a prospective study analyzing specimens from fifty subjects. Patients scheduled to undergo breast-conserving surgery will be recruited in accordance with the inclusion and exclusion criteria. The study period per subject is the time it takes to assess the ex vivo breast tissue sample using the study device. Image review will be conducted during surgery and compared to the margin status findings in the post-operative pathology report.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with breast cancer undergoing lumpectomy.
Key inclusion criteria (4 listed)
- Women 18 years of age or older
- Signed informed consent form
- Women who have been histologically diagnosed with carcinoma of the breast prior to surgery
- Patients planning breast preservation and undergoing lumpectomy (partial mastectomy) procedure
Key exclusion criteria (9 listed)
- Multicentric disease (histologically diagnosed cancer in two different quadrants of the breast)
- Neoadjuvant systemic therapy
- All T4 tumors
- Previous radiation in the operated breast
- Prior surgical procedure in the same quadrant
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 |
|---|---|---|
| Interferometric Synthetic Aperture MicroscopyAlso: Optical Coherence TomographyOptical coherence tomography with interferometric synthetic aperture microscopy will be used to image ex vivo breast tissue specimens. | Device | – |
Primary outcome
Patients With All Positive/Close Margins Correctly Identified With the Device
Time frame: 1 week after surgery
Number of Margins With False Positive Device Readings
Time frame: 1 week after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2019.
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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.
Lisa Jacobs principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Diagnostic Photonics, Inc. 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 4 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: paused, as of the sponsor's last update on 18 Jul 2019. 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?
Patients With All Positive/Close Margins Correctly Identified With the Device (time frame: 1 week after surgery). The study lists 2 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 18 Jul 2019.