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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
  Purpose

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.


Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Optical Spectroscopy During Breast Cancer Surgery and Core Needle Biopsy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Duke University:

Biospecimen Retention:   Samples With DNA

Research Biopsies


Estimated Enrollment: 377
Study Start Date: January 2006
Estimated Study Completion Date: March 2015
Groups/Cohorts
1
Patients needing a needle biopsy of a breast mass
2
Patients needing a partial or simple mastectomy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • pregnant women
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00734838

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27708
Sponsors and Collaborators
Duke University
William Marsh Rice University
Investigators
Principal Investigator: Nimmi Ramanujam, PhD Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00734838     History of Changes
Other Study ID Numbers: Pro00008003, NIH 5R01-CA-100559, W81XWH-09-1-0410
Study First Received: August 13, 2008
Last Updated: November 15, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Breast Cancer
Breast Biopsy
Simple Mastectomy
Partial Mastectomy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 19, 2013