Fast Spectral Imaging Device for Tumor Margin Mapping

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

54 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-30

Study Completion Date

2011-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Reproducibility

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

No interventions assigned to this group

Eligibility Criteria

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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