CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 enrolled
Drug / intervention
Optical coherence tomographydevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01699867
NCT01699867N/ACompleted
CompareCT.gov

Computed Optical Margin Assessment for Breast Cancer Surgery, Phase I (Part A)

Diagnostic Photonics, Inc.·observational·Posted Oct 4, 2012·Updated Jan 6, 2015

In Brief

An observational study evaluating Optical coherence tomography for Breast Cancer. Completed, enrolled 50 participants across 2 sites.

Detailed Summary

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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
CollaboratorsJohns Hopkins University

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 4, 2012
Enrollment StartDec 1, 2012
Primary CompletionMay 1, 2013
Study CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 13.7 years ago

Interventions

Optical coherence tomographydevice

Optical coherence tomography was used to image ex vivo breast tissue specimens.