Fast Spectral Imaging Device for Tumor Margin Mapping

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01107080
First received: April 18, 2010
Last updated: February 6, 2013
Last verified: February 2013
  Purpose

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
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Fast Spectral Imaging Device for Tumor Margin Mapping

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • To perform a critical evaluation of the device in a practical clinical setting [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    (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.


Enrollment: 54
Study Start Date: September 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01107080

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
Study Chair: Nimmi Ramanujam, PhD Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01107080     History of Changes
Other Study ID Numbers: Pro00017428, 2R42CA128160-02
Study First Received: April 18, 2010
Last Updated: February 6, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on October 28, 2014