Fast Spectral Imaging Device for Tumor Margin Mapping

Completed

• Conditions: Breast Cancer

• Registration Number: NCT01107080
• Lead Sponsor: Duke University

Brief Summary

The objective of the proposed research is to develop a clinical-trial-ready device and to evaluate its practical utility as a routinely used intra-operative tool. Our multidisciplinary group has previously shown that optical techniques can effectively discriminate between malignant and non-malignant breast tissues. The proposed technology will be a multi-channel optical assay device for intra-operative imaging of margins in specimens excised from patients undergoing breast conserving surgery (partial mastectomy) or mastectomy.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2010-04-18
• Study First Submitted QC: 2010-04-18
• Study First Posted: 2010-04-20
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-06
• Last Update Posted: 2013-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 54

Inclusion Criteria

• Patients undergoing a partial mastectomy or mastectomy for the treatment of an invasive or non-invasive breast malignancy
• Age > 18
• Clinically detectable disease either by physical examination or radiographic studies
• Patients of all ethnic and gender groups will be included. Protocol accrual will be reviewed annually to include a determination of minority and gender representation. If accrual demonstrates under representation of any group with comparison to disease incidence in that group, appropriate measures will be undertaken to increase participation of patients of that minority or gender group.
• Ability to understand and the willingness to sign a written informed consent document

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Exclusion Criteria

• Patients considered in "vulnerable" populations

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To perform a critical evaluation of the device in a practical clinical setting	2 years	(1) In order to define the effective post-excision time window in which the device must be used, which ultimately has bearings on the final product indications for use. (2)To analyze the different methods of implementation of the technology.

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States