Optical Spectroscopy During Breast Cancer Surgery and Core Needle Biopsy

NCT ID: NCT00734838

Last Updated: 2023-08-14

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

Clinical Phase

NA

Total Enrollment

213 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2022-10-03

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Core needle biopsy

Patients needing a needle biopsy of a breast mass

Group Type EXPERIMENTAL

High Resolution Microendoscope

Intervention Type DEVICE

Using core biopsy and reduction mammoplasty tissue

Reduction mammoplasty

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

Group Type PLACEBO_COMPARATOR

High Resolution Microendoscope

Intervention Type DEVICE

Using core biopsy and reduction mammoplasty tissue

Interventions

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High Resolution Microendoscope

Using core biopsy and reduction mammoplasty tissue

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients having a needle biopsy of a breast mass

Exclusion Criteria

* none
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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William Marsh Rice University

OTHER

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nimmi Ramanujam, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke University Medical Center

Durham, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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NIH 5R01-CA-100559

Identifier Type: -

Identifier Source: secondary_id

W81XWH-09-1-0410

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Pro00008003

Identifier Type: -

Identifier Source: org_study_id

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