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Optical Spectroscopy During Breast Cancer Surgery and Core Needle Biopsy

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2016 by Duke University
Sponsor:
Collaborator:
William Marsh Rice University
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00734838
First received: August 13, 2008
Last updated: December 19, 2016
Last verified: November 2016

August 13, 2008
December 19, 2016
January 2006
December 2018   (Final data collection date for primary outcome measure)
Optical signatures [ Time Frame: Day of procedure (less than 10 minutes) ]
The primary outcome of this study is the identification of the optical signatures of normal and cancerous tissue of the breast
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Complete list of historical versions of study NCT00734838 on ClinicalTrials.gov Archive Site
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Optical Spectroscopy During Breast Cancer Surgery and Core Needle Biopsy
Optical Spectroscopy During Breast Cancer Surgery and Core Needle Biopsy
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.
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Interventional
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Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
Device: High Resolution Microendoscope
Using core biopsy and reduction mammoplasty tissue
  • Experimental: Core needle biopsy
    Patients needing a needle biopsy of a breast mass
    Intervention: Device: High Resolution Microendoscope
  • Placebo Comparator: Reduction mammoplasty
    Any patients scheduled for a reduction mammoplasty who would like to participate in a study to better understand breast cancer
    Intervention: Device: High Resolution Microendoscope
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
162
December 2018
December 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients having a needle biopsy of a breast mass

Exclusion Criteria:

Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
Yes
Contact: Nimmi Ramanujam, Ph.D. (919) 660-5307
United States
 
 
NCT00734838
Pro00008003
NIH 5R01-CA-100559
W81XWH-09-1-0410 ( Other Grant/Funding Number: Department of Defense )
Yes
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Duke University
Duke University
William Marsh Rice University
Principal Investigator: Nimmi Ramanujam, PhD Duke University
Duke University
November 2016

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