Fast Spectral Imaging Device for Tumor Margin Mapping

Duke University

Status: Completed

Conditions: Breast Cancer

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT01107080

2R42CA128160-02 (U.S. NIH Grant/Contract)

Pro00017428

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

54 participants in 2 patient groups

Degradation

Description:

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

Description:

25 Partial Mastectomy cases will be analyzed to distinguish between different implementation methods of the technology.