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Optical Spectroscopy During Breast Cancer Surgery and Core Needle Biopsy

Primary Purpose

Breast Cancer

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

High Resolution Microendoscope

About this trial

This is an interventional device feasibility trial for Breast Cancer focused on measuring Breast Cancer, Breast Biopsy, Reduction mammoplasty

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Patients having a needle biopsy of a breast mass

Exclusion Criteria:

none

Sites / Locations

Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Core needle biopsy

Reduction mammoplasty

Arm Description

Patients needing a needle biopsy of a breast mass

Any patients scheduled for a reduction mammoplasty who would like to participate in a study to better understand breast cancer

Outcomes

Primary Outcome Measures

Optical signatures

The primary outcome of this study is the identification of the optical signatures of normal and cancerous tissue of the breast

Secondary Outcome Measures

Full Information

NCT ID

NCT00734838

First Posted

August 13, 2008

Last Updated

August 10, 2023

Sponsor

Duke University

Collaborators

William Marsh Rice University

1. Study Identification

Unique Protocol Identification Number

NCT00734838

Brief Title

Optical Spectroscopy During Breast Cancer Surgery and Core Needle Biopsy

Official Title

Optical Spectroscopy During Breast Cancer Surgery and Core Needle Biopsy

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

January 2006 (undefined)

Primary Completion Date

October 3, 2022 (Actual)

Study Completion Date

October 3, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

Collaborators

William Marsh Rice University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The objective of the proposed research is to develop new diagnostic modalities based on optical spectroscopy (auto fluorescence, absorption, and scattering) for the diagnosis of breast cancer and test its performance as an adjunct to core needle biopsy. For the surgery part of the study, all patients scheduled to have a mastectomy or lumpectomy for the treatment of breast cancer will be asked if they would be willing to participate in this study. For the core needle biopsy part of the study, patients with a higher pre-probability of cancer (based on mammography) will be recruited to increase the number of patients with malignant lesions and enrolled in this investigation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

Breast Cancer, Breast Biopsy, Reduction mammoplasty

7. Study Design

Primary Purpose

Device Feasibility

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

213 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Core needle biopsy

Arm Type

Experimental

Arm Description

Patients needing a needle biopsy of a breast mass

Arm Title

Reduction mammoplasty

Arm Type

Placebo Comparator

Arm Description

Any patients scheduled for a reduction mammoplasty who would like to participate in a study to better understand breast cancer

Intervention Type

Device

Intervention Name(s)

High Resolution Microendoscope

Intervention Description

Using core biopsy and reduction mammoplasty tissue

Primary Outcome Measure Information:

Title

Optical signatures

Description

The primary outcome of this study is the identification of the optical signatures of normal and cancerous tissue of the breast

Time Frame

Day of procedure (less than 10 minutes)

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients having a needle biopsy of a breast mass Exclusion Criteria: none

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nimmi Ramanujam, PhD

Organizational Affiliation

Duke University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Duke University Medical Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27708

Country

United States

12. IPD Sharing Statement

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Optical Spectroscopy During Breast Cancer Surgery and Core Needle Biopsy

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