NCT00734955

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
485

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started May 2006

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

August 13, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 14, 2008

Completed
8.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

May 15, 2020

Status Verified

May 1, 2020

Enrollment Period

11.2 years

First QC Date

August 13, 2008

Last Update Submit

May 14, 2020

Conditions

Breast Cancer

Keywords

Partial MastectomyLumpectomyMastectomy

Outcome Measures

Primary Outcomes (1)

  • Identification of the optical signatures of breast tissue.

    The primary outcome measure of this study is to identify the optical signatures of normal and cancerous tissue.

    Day of procedure

Study Arms (3)

Reduction Mammoplasty

EXPERIMENTAL

Patients undergoing reduction mammoplasty

Device: 49-channel optical spectrometer

Mastectomy

EXPERIMENTAL

Patients undergoing mastectomy

Device: 49-channel optical spectrometer

Lumpectomy

EXPERIMENTAL

Patients undergoing a lumpectomy

Device: 49-channel optical spectrometer

Interventions

49-channel optical spectrometerDEVICE
LumpectomyMastectomyReduction Mammoplasty

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of Breast Cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27708, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Nimmi Ramanujam, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2008

First Posted

August 14, 2008

Study Start

May 1, 2006

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

May 15, 2020

Record last verified: 2020-05

Locations

US(1)