Trial Outcomes & Findings for Computed Optical Margin Assessment for Breast Cancer Surgery, Phase I (Part A) (NCT NCT01699867)

NCT ID: NCT01699867

Last Updated: 2015-01-06

Results Overview

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").

• Recruitment status: COMPLETED
• Target enrollment: 50 participants
• Primary outcome timeframe: one week after surgery
• Results posted on: 2015-01-06

Participant Flow

Participant milestones

Measure	Optical Coherence Tomography (Single-arm) Specimens from all patients were evaluated by optical coherence tomography.
Overall Study STARTED	50
Overall Study COMPLETED	47
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Optical Coherence Tomography (Single-arm) Specimens from all patients were evaluated by optical coherence tomography.
Overall Study Screening Failure	3

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Optical Coherence Tomography (Single-arm) n=46 Participants Specimens from all patients were evaluated by optical coherence tomography.
Age, Continuous	62 years n=5 Participants
Sex: Female, Male Female	46 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: one week after surgery

Population: Patients with positive margins (0 mm, "tumor on ink").

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").

Outcome measures

Measure	Optical Coherence Tomography (Single-arm) n=8 Participants Specimens from all patients were evaluated by optical coherence tomography.
Patients With All Positive Margins Correctly Identified With the Device	5 Patients w/ all positives identified

PRIMARY outcome

Timeframe: one week after surgery

Population: Patients with all negative margins (≥ 2 mm). On average, 5 out of 6 possible margins were analyzed per patient.

Outcome measures

Measure	Optical Coherence Tomography (Single-arm) n=35 Participants Specimens from all patients were evaluated by optical coherence tomography.
Number of Margins With False Positive Device Readings	1.32 False positive margins per patient Standard Deviation 1.38

Adverse Events

All Patients (Single-arm)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lisa K. Jacobs, M.D.

Johns Hopkins Medicine

Phone: 410-502-0880

Email: ljacob14@jhmi.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place