Fast Spectral Imaging Device for Tumor Margin Mapping

Breast Cancer Clinical Trial

Official title:

Fast Spectral Imaging Device for Tumor Margin Mapping

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01107080
• Other study ID #: Pro00017428
• Secondary ID: 2R42CA128160-02
• Status: Completed
• Phase: N/A
• First received: April 18, 2010
• Last updated: February 6, 2013
• Start date: September 2009
• Est. completion date: September 2011

Study information

• Verified date: February 2013
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Exclusion Criteria:

• Patients considered in "vulnerable" populations

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Duke University	National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To perform a critical evaluation of the device in a practical clinical setting	(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.	2 years	No