Fast Spectral Imaging Device for Tumor Margin Mapping

NCT01107080 | Completed DMC

• 2 other identifiers: Pro000174282R42CA128160-02
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

breast cancer; breast carcinoma in situ; ductal breast carcinoma in situ; invasive carcinoma; invasive ductal carcinoma; invasive lobular carcinoma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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 Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

There are 2 groups of patients and each group contains 20 participants.

You may qualify if:

• 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

You may not qualify if:

• Patients considered in "vulnerable" populations

Sponsors & Collaborators

• Duke University: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Breast Carcinoma In Situ; Carcinoma, Intraductal, Noninfiltrating; Carcinoma, Lobular

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma in Situ; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Adenocarcinoma; Neoplasms, Ductal, Lobular, and Medullary

Study Officials

• Nimmi Ramanujam, PhD

  Duke University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2010
• First Posted: April 20, 2010
• Study Start: September 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: February 7, 2013

Record last verified: 2013-02

Locations

US (1)