Fast Spectral Imaging Device for Tumor Margin Mapping

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01107080

Enrollment

Registered

2010-04-20

Start date

2009-09-30

Completion date

2011-09-30

Last updated

2013-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
To perform a critical evaluation of the device in a practical clinical setting	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.

Countries

United States

Outcome results