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Fast Spectral Imaging Device for Tumor Margin Mapping

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01107080
Recruitment Status : Completed
First Posted : April 20, 2010
Last Update Posted : February 7, 2013
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Breast Cancer

Study Design

Study Type : Observational
Actual Enrollment : 54 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Fast Spectral Imaging Device for Tumor Margin Mapping
Study Start Date : September 2009
Primary Completion Date : September 2011
Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Degradation
30 mastectomy, partial mastectomy, and mammoplasty samples will be analyzed to define the effective post-excision time window in which the device must be used before the results can no longer be evaluated. The mammoplasty specimens are necessary to assess normal tissue outcomes.
Reproducibility
25 Partial Mastectomy cases will be analyzed to distinguish between different implementation methods of the technology.


Outcome Measures

Primary Outcome Measures :
  1. To perform a critical evaluation of the device in a practical clinical setting [ Time Frame: 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
There are 2 groups of patients and each group contains 20 participants.
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01107080


Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Investigators
Study Chair: Nimmi Ramanujam, PhD Duke University
More Information

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01107080     History of Changes
Other Study ID Numbers: Pro00017428
2R42CA128160-02 ( U.S. NIH Grant/Contract )
First Posted: April 20, 2010    Key Record Dates
Last Update Posted: February 7, 2013
Last Verified: February 2013

Keywords provided by Duke University:
breast cancer
breast carcinoma in situ
ductal breast carcinoma in situ
invasive carcinoma
invasive ductal carcinoma
invasive lobular carcinoma