Optical Spectroscopy During Breast Cancer Surgery and Core Needle Biopsy

This study has suspended participant recruitment.

Sponsor:

Collaborator:

William Marsh Rice University

Information provided by (Responsible Party):

Duke University

ClinicalTrials.gov Identifier:

NCT00734838

First received: August 13, 2008

Last updated: November 15, 2012

Last verified: November 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

August 13, 2008

Last Updated Date

November 15, 2012

Start Date ^ICMJE

January 2006

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00734838 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Optical Spectroscopy During Breast Cancer Surgery and Core Needle Biopsy

Official Title ^ICMJE

Optical Spectroscopy During Breast Cancer Surgery and Core Needle Biopsy

Brief Summary

The objective of the proposed research is to develop new diagnostic modalities based on optical spectroscopy (auto fluorescence, absorption, and scattering) for the diagnosis of breast cancer and test its performance as an adjunct to core needle biopsy. For the surgery part of the study, all patients scheduled to have a mastectomy or lumpectomy for the treatment of breast cancer will be asked if they would be willing to participate in this study. For the core needle biopsy part of the study, patients with a higher pre-probability of cancer (based on mammography) will be recruited to increase the number of patients with malignant lesions and enrolled in this investigation.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case-Only
Time Perspective: Retrospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples With DNA

Description:

Research Biopsies

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing partial or simple mastectomy or patients having a needle biopsy of a breast mass

Condition ^ICMJE

Breast Cancer

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

1
Patients needing a needle biopsy of a breast mass
2
Patients needing a partial or simple mastectomy

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Suspended

Estimated Enrollment ^ICMJE

377

Estimated Completion Date

March 2015

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients undergoing partial or simple mastectomy
Patients having a needle biopsy of a breast mass

Exclusion Criteria:

pregnant women

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00734838

Other Study ID Numbers ^ICMJE

Pro00008003, NIH 5R01-CA-100559, W81XWH-09-1-0410

Has Data Monitoring Committee

Yes

Responsible Party

Duke University

Study Sponsor ^ICMJE

Duke University

Collaborators ^ICMJE

William Marsh Rice University

Investigators ^ICMJE

Principal Investigator:

Nimmi Ramanujam, PhD

Duke University

Information Provided By

Duke University

Verification Date

November 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top