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Light-Scattering Spectroscopy for Detection of Breast Cancer

NCT ID: NCT01755208

Last Updated: 2021-11-19

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

TERMINATED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-21

Study Completion Date

2020-11-19

Brief Summary

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This pilot clinical trial studies light-scattering spectroscopy in finding disease in patients with stage II-III breast cancer. Diagnostic procedures, such as light-scattering spectroscopy, may help find and diagnose breast cancer

Detailed Description

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PRIMARY OBJECTIVES: I. To evaluate whether light-scattering spectroscopy can reliably distinguish between two subject groups: those with clinical stage II or stage III breast cancer and those without breast cancer.

OUTLINE: Patients undergo light-scattering spectroscopy of the breast in addition to standard of care as it relates to screening for breast cancer or treatment of breast cancer.

Conditions

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Healthy, no Evidence of Disease Stage II Breast Cancer Stage IIIA Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Diagnostic (light-scattering spectroscopy)

Patients undergo light-scattering spectroscopy of the breast in addition to standard of care as it relates to screening for breast cancer or treatment of breast cancer.

Group Type EXPERIMENTAL

light-scattering spectroscopy

Intervention Type PROCEDURE

Undergo light-scattering spectroscopy

Interventions

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light-scattering spectroscopy

Undergo light-scattering spectroscopy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Participants who are breast cancer free (mammogram "negative" within 1 month of testing) with the absence of clinical suspicion of breast cancer on physical exam or with clinical stage II or stage III breast cancer. PLEASE NOTE: Recruitment for this study is only limited to patients who are scheduled for a mammogram at USC. There is no compensation to participants.
* Provision of informed consent prior to any study-related procedures

Exclusion Criteria

* Females with tattoos on either or both breasts
* Females with nipple piercings on either or both breasts
* Females with skin piercings (aka microdermal anchor surface or microdermal piercings) in either or both breasts
* Females unable to provide informed consent
* Females s/p treatment for breast cancer
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Southern California

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jacques Van Dam

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

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USC Norris Comprehensive Cancer Center

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2012-02769

Identifier Type: REGISTRY

Identifier Source: secondary_id

1B-12-6

Identifier Type: -

Identifier Source: org_study_id