An observational study in Breast Cancer, sponsored by Diagnostic Photonics, Inc.. Completed at 2 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-01-06.
Sponsored by Diagnostic Photonics, Inc. · Observational
This multi-center, prospective, open label study analyzed specimens from fifty subjects at two study sites. Patients scheduled to undergo breast-conserving surgery were recruited in accordance with the inclusion and exclusion criteria. The study period per subject was the time it took to assess the ex vivo breast tissue sample using the study device. Image review was conducted after surgery and compared to the margin status findings in the post-operative pathology report.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 50 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Diagnostic Photonics, Inc. is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Women with breast cancer undergoing lumpectomy
Exclusion Criteria:
Optical coherence tomography was used to image ex vivo breast tissue specimens.
Patients With All Positive Margins Correctly Identified With the Device
In this study, a patient had "positive margins" if tumor was identified at the true margin (i.e., the final margin or new margin) surface of at least one specimen by histology (0 mm, "tumor on ink").
Time frame: one week after surgery
Number of Margins With False Positive Device Readings
Time frame: one week after surgery
| Milestone | Optical Coherence Tomography (Single-arm) |
|---|---|
| Started | 50 |
| Completed | 47 |
| Not completed | 3 |
| Withdrew: Screening failure | 3 |
In this study, a patient had "positive margins" if tumor was identified at the true margin (i.e., the final margin or new margin) surface of at least one specimen by histology (0 mm, "tumor on ink").
| Patients w/ all positives identified | Optical Coherence Tomography (Single-arm) |
|---|---|
| Patients With All Positive Margins Correctly Identified With the Device | 5 |
| False positive margins per patient | Optical Coherence Tomography (Single-arm) |
|---|---|
| Number of Margins With False Positive Device Readings | 1.32 ± 1.38 |
Collected over During the surgical procedure.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All Patients (Single-arm) | — | 0/47 (0%) | 0/47 (0%) |
47 patients completed the study. 1 patient was excluded from the analysis due to insufficient images in all specimens (did not meet protocol specifications).
| Age, Continuous(years) | Optical Coherence Tomography (Single-arm) |
|---|---|
| Mean | 62 (27 to 81) |
| Sex: Female, Male(Participants) | Optical Coherence Tomography (Single-arm) |
|---|---|
| Female | 46 |
| Male | 0 |
This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.
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Diagnostic Photonics, Inc.