Monitoring the Response of Chemotherapy on Breast Cancer Tumor by Photon Migration Spectroscopy

NCT ID: NCT00540852

Last Updated: 2022-11-01

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

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-06-30

Study Completion Date

2011-01-31

Brief Summary

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Optimal management of patients with locally advanced breast cancer remains a complex therapeutic problem. Newly diagnosed breast cancers in the United States with a higher incidence in medically underserved areas. The optimal intensity and duration of neoadjuvant chemotherapy still remains controversial due to the difficulty of evaluating response to therapy. The goal would be to prevent over and under treatment of patients with neoadjuvant chemotherapy.

Detailed Description

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The Researcher developed a diagnostic device called Diffuse Optical Spectroscopy Imaging is a non-invasive optical technique that utilizes intensity-modulated, near-infrared light to quantitatively measure optical properties in thick tissues.

Diffuse Optical Spectroscopy Imaging can images tissue hemoglobin , oxygen saturation, blood volume fraction, water content, fat content and cellular structure. The measurements provide quantitative optical property values that reflect changes in tissue perfusion, oxygen consumption, and cell/matrix development.

There is no therapeutic benefit to the subject, especially none that might influence the indication for the diagnostic procedure as indicated. However, information obtained may lead to a new form of non-invasive imaging for the early detection of breast cancer.

Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Study Groups

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Diagnostic Tool

Diffuse Optical Spectroscopy Imaging

Group Type OTHER

Diffuse Optical Spectroscopy Imaging

Intervention Type DEVICE

Diffuse Optical Spectroscopy Imaging

Interventions

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Diffuse Optical Spectroscopy Imaging

Diffuse Optical Spectroscopy Imaging

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Female non-pregnant and age greater than or equal to 21 years old but less than 75 years old
* Diagnosed with breast cancer and will be receiving neoadjuvant chemotherapy

Exclusion Criteria

* Female pregnant and age less than 21 years old and have no diagnosis of breast cancer
Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Beckman Laser Institute University of California Irvine

OTHER

Sponsor Role collaborator

Chao Family Comprehensive Cancer Center

OTHER

Sponsor Role collaborator

University of California, Irvine

OTHER

Sponsor Role lead

Responsible Party

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Beckman Laser Institute and Medical Center

David Hsiang, M.D., Division of Surgical Oncology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David Hsiang, M.D

Role: PRINCIPAL_INVESTIGATOR

Beckman Laser Institute University of California Irvine

Locations

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Beckman Laser Institute University Of California Irvine

Irvine, California, United States

Site Status

Chao Family Comprehensive Cancer Center

Orange, California, United States

Site Status

Countries

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United States

Other Identifiers

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20022306

Identifier Type: -

Identifier Source: org_study_id

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