Clinical trial NCT01372631: A Novel Optical Spectral Imaging System for Imaging Breast Tumor Margins
Official title: A Novel Optical Spectral Imaging System for Imaging Breast Tumor Margins
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Reduction mammoplasty
mastectomy
partial mastectomy
lumpectomy
breast conserving surgery
breast cancer
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute for Biomedical Imaging and Bioengineering (NIBIB)
First posted: 2011-06-14
Enrollment: 218
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The goal of this research is to further develop novel optical assay systems for intra operative assessment of tumor margins in partial mastectomy or mastectomy specimens.

Detailed description: The goal of this research is to further develop novel optical assay systems for intra operative assessment of tumor margins in partial mastectomy or mastectomy specimens. We are seeking to establish the accuracy of first and second-generation prototypes of technologies utilizing optical spectroscopy for intra operative margin assessment in partial mastectomy or mastectomy specimens. The aims associated with this research are as follows, (1) to evaluate the device-tissue interface on reduction mammoplasty specimens from a total of 20 patients, (2) to assess random and systematic errors of the new miniature system on mastectomy specimens from a total of 40 patients (3) to test the sensitivity, and specificity of the miniature spectral imaging system for margin assessment on excised partial mastectomy or mastectomy specimens from a total of 150 patients undergoing breast conserving surgery.

Last patient's surgery took place in 2017 and recruitment remained open. Later the team encountered staffing issues; therefore the study status was updated to suspended. We recently made the decision to no longer attempt to enroll the remaining 2 subjects and focus on the data analysis only.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing a reduction mammoplasty OR
* Patients undergoing a lumpectomy 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.

Primary outcomes:
measure: Identification of the optical signatures in breast tissue
timeFrame: Day of procedure (less than 10 minutes)
Secondary outcomes:
measure: Sensitivity and Specificity of the device
timeFrame: Day of procedure (less than 10 minutes)
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Madison
country: United States
facility: University of Wisconsin - Madison
state: Wisconsin
Study officials:
affiliation: Duke University
name: Nimmi Ramanujam, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: