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

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Device: Diffuse Optical Spectroscopy Imaging

• Registration Number: NCT00540852
• Lead Sponsor: University of California, Irvine

Brief Summary

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

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.

Study Timeline

• Study Start: 2002-06
• Study First Submitted: 2007-10-04
• Study First Submitted QC: 2007-10-04
• Study First Posted: 2007-10-08
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-28
• Last Update Posted: 2022-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 77

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

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Exclusion Criteria

• Female pregnant and age less than 21 years old and have no diagnosis of breast cancer

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic Tool	Diffuse Optical Spectroscopy Imaging	Diffuse Optical Spectroscopy Imaging

Primary Outcome Measures

Name	Time	Method
Diagnostic tool	12 weeks	Diffuse Optical Spectroscopy Imaging Breast Cancer Tumor in the response of Chemotherapy

Trial Locations

Locations (2)

Chao Family Comprehensive Cancer Center; 🇺🇸 Orange, California, United States

Beckman Laser Institute University Of California Irvine; 🇺🇸 Irvine, California, United States