Optical Spectroscopy During Breast Cancer Surgery and Core Needle Biopsy

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 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: October 6, 2014
Last verified: October 2014

August 13, 2008
October 6, 2014
January 2006
March 2015   (final data collection date for primary outcome measure)
Optical signatures [ Time Frame: Day of procedure (less than 10 minutes) ] [ Designated as safety issue: No ]
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: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Device: High Resolution Microendoscope
  • Device: Bench-top optical spectrometer
Experimental: Core needle biopsy
Patients needing a needle biopsy of a breast mass
Interventions:
  • Device: High Resolution Microendoscope
  • Device: Bench-top optical spectrometer
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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
377
March 2015
March 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients having a needle biopsy of a breast mass

Exclusion Criteria:

  • none
Both
18 Years and older
Yes
Contact: Nimmi Ramanujam, Ph.D. (919) 660-5307
United States
 
NCT00734838
Pro00008003, NIH 5R01-CA-100559, W81XWH-09-1-0410
Yes
Duke University
Duke University
William Marsh Rice University
Principal Investigator: Nimmi Ramanujam, PhD Duke University
Duke University
October 2014

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