Fast Spectral Imaging Device for Tumor Margin Mapping

Trial Information

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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

To perform a critical evaluation of the device in a practical clinical setting

Outcome Description:

(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.

Outcome Time Frame:

2 years

Safety Issue:

Principal Investigator

Nimmi Ramanujam, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Duke University

Authority:

United States: Food and Drug Administration

Study ID:

Pro00017428

NCT ID:

NCT01107080

Start Date:

September 2009

Completion Date:

September 2011

Related Keywords:

Breast Cancer
breast cancer
breast carcinoma in situ
ductal breast carcinoma in situ
invasive carcinoma
invasive ductal carcinoma
invasive lobular carcinoma
Breast Neoplasms

Name	Location
Duke University Medical Center	Durham, North Carolina 27710

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