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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00540852
• Other study ID #: 20022306
• Status: Completed
• Phase: N/A
• Start date: June 2002
• Est. completion date: January 2011

Study information

• Verified date: October 2022
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Device:
• Diffuse Optical Spectroscopy Imaging
Diffuse Optical Spectroscopy Imaging

Locations

Country	Name	City	State
United States	Beckman Laser Institute University Of California Irvine	Irvine	California
United States	Chao Family Comprehensive Cancer Center	Orange	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, Irvine	Beckman Laser Institute University of California Irvine, Chao Family Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic tool	Diffuse Optical Spectroscopy Imaging Breast Cancer Tumor in the response of Chemotherapy	12 weeks