Spectroscopy of Breast Tissue
3 other identifiers
observational
141
1 country
1
Brief Summary
RATIONALE: Diagnostic procedures, such as laser spectroscopy, may help find and diagnose breast cancer. PURPOSE: This phase I trial is studying laser spectroscopy to see how well it works in diagnosing breast cancer in women with breast lesions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2008
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 10, 2009
CompletedFirst Posted
Study publicly available on registry
June 11, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedJuly 16, 2014
July 1, 2014
5.6 years
June 10, 2009
July 14, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Ability of laser spectroscopy performed ex vivo to effectively distinguish between benign and malignant breast tumors
The data will be taken with a portable spectroscopy system that can perform fluorescence, reflectance and Raman spectroscopy simultaneously through a single fiber optic probe.
At the time of biopsy
Interventions
Additional histochemical, immunohistochemical, and fluorescence in situ stains may be performed to support the diagnosis or to better understand the spectroscopy results.
Additional histochemical, immunohistochemical, and fluorescence in situ stains may be performed to support the diagnosis or to better understand the spectroscopy results.
Patients' medical charts are reviewed to obtain clinical information
The freshly excised breast tissue samples are analyzed ex vivo by fluorescence, reflectance, and/or Raman spectroscopy.
Hematoxylin and eosin stained sections of the tissue samples are examined by light microscopy for histopathological analysis.
The freshly excised breast tissue samples are analyzed ex vivo by fluorescence, reflectance, and/or Raman spectroscopy.
Eligibility Criteria
This study will involve up to 200 female patients already undergoing needle biopsy or surgical excision of a breast lesion identified clinically. The patients will be recruited from the General Surgery and Radiology practices of the co-investigators.
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- Case Comprehensive Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065, United States
Biospecimen
This study will involve up to 200 female patients already undergoing needle biopsy or surgical excision of a breast lesion identified clinically.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maryann Fitzmaurice, MD
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2009
First Posted
June 11, 2009
Study Start
March 1, 2008
Primary Completion
October 1, 2013
Study Completion
October 1, 2013
Last Updated
July 16, 2014
Record last verified: 2014-07