An Optical Assay System for Intra Operative Assessment of Tumor Margins in Patients

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00734955

Enrollment

485

Registered

2008-08-14

Start date

2006-05-31

Completion date

2017-07-31

Last updated

2020-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Partial Mastectomy, Lumpectomy, Mastectomy

Brief summary

Our objective is to develop a novel optical assay system for intra operative assessment of tumor margins in partial mastectomy or mastectomy specimens. Our group has previously shown that optical techniques can effectively discriminate between malignant and non-malignant breast tissues. We have also shown that data collection and processing from a single point on the tissue specimen requires less than 5 seconds. In addition, the technique is easily adaptable to provide sensing depths that are required for breast margin assessment. The goal of the work proposed in this protocol is to test the sensitivity and specificity of an optical assay system developed by our group, for intra operative assessment of breast tumor margins.

Interventions

DEVICE49-channel optical spectrometer

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DEVICE_FEASIBILITY

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Clinical diagnosis of Breast Cancer

Design outcomes

Primary

Measure	Time frame	Description
Identification of the optical signatures of breast tissue.	Day of procedure	The primary outcome measure of this study is to identify the optical signatures of normal and cancerous tissue.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026