Expired Study
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Durham, North Carolina 27708


Purpose:

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.


Criteria:

Inclusion Criteria: - Clinical diagnosis of Breast Cancer Exclusion Criteria:


Study is Available At:


Original ID:

Pro00007857


NCT ID:

NCT00734955


Secondary ID:

1R01EB011574-01A1


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Suspended


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Duke University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:

Study on-hold. Study staff no longer with Du


Study Type:

Interventional


Study Design:


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

530


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Nimmi Ramanujam, PhD
Principal Investigator
Duke University

Study Dates

Start Date:May 2006
Completion Date:December 2019
Completion Type:Anticipated
Primary Completion Date:December 2019
Primary Completion Type:Anticipated
Verification Date:May 2019
Last Changed Date:July 17, 2019
First Received Date:August 13, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:Identification of the optical signatures of breast tissue.
Time Frame:Day of procedure
Safety Issues:False
Description:The primary outcome measure of this study is to identify the optical signatures of normal and cancerous tissue.

Study Interventions

Intervention Type:Device
Name:49-channel optical spectrometer
Arm Name:Reduction Mammoplasty

Study Arms

Study Arm Type:Experimental
Arm Name:Lumpectomy
Description:Patients undergoing a lumpectomy
Study Arm Type:Experimental
Arm Name:Mastectomy
Description:Patients undergoing mastectomy
Study Arm Type:Experimental
Arm Name:Reduction Mammoplasty
Description:Patients undergoing reduction mammoplasty

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Duke University
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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