Monitoring and Predicting Breast Cancer Neoadjuvant Chemotherapy Response Using DOSI

Breast Tumor Clinical Trial

Official title:

Monitoring and Predicting Breast Cancer Neoadjuvant Chemotherapy Response Using Diffuse Optical Spectroscopic Imaging in a Multi-Center Setting

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02725658
• Other study ID #: 20152355
• Status: Withdrawn
• Phase: N/A
• Start date: December 2015
• Est. completion date: December 2019

Study information

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

Clinical Trial Summary

The purpose of this research study is to help us learn if an experimental imaging device called Diffuse Optical Spectroscopic Imaging (DOSI) can monitor tumor shrinkage during chemotherapy treatment and can predict if the tumor will respond to chemotherapy before the end of the treatment. This study will also help us understand the biological reason for how DOSI works.

Description:

There is considerable interest in developing imaging protocols to monitor and predict breast cancer response to neoadjuvant chemotherapy (NAC), which is chemotherapy given before surgical removal of the tumor, both prior to and as early as possible during the course of treatment. The efficacy and practicality of conventional imaging approaches in the NAC setting varies and identifies the need for alternate functional imaging strategies. Diffuse optical spectroscopic imaging (DOSI) is an experimental imaging method that allows patients to be followed before and during treatment with a cost-effective, bedside, handheld scanning probe. DOSI is a non-invasive technology developed at the University of California, Irvine Beckman Laser Institute. Studies will be performed at seven clinical sites on approximately 200 suspected breast cancer patients, of which 150 are expected to undergo neoadjuvant chemotherapy (NAC).

As a primary aim, the investigators will evaluate whether DOSI can predict NAC pathologic complete response (pCR), which is defined as no tumor cell left in the resected tissue at surgery) by the mid-point of the therapy regimen. As non-invasive DOSI is obtained rapidly with no risk/discomfort, this experimental imaging modality could be used as an indicator of pathologic response which has been an established indicator of long-term survival. The investigators long-term goal is to provide oncologists with a relatively simple, risk-free bedside tool that can be used to help inform medical decisions on chemotherapy regimen, duration, and timing of surgery, thereby maximizing therapeutic response and minimizing unnecessary toxicity.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 80 Years

Eligibility

Inclusion Criteria:

• Females between the ages of 21 and 80. Specific to Study part #1

• Diagnosed with a Breast Imaging-Reporting and Data System score of 4 or higher breast abnormality greater than 1cm in size Specific to Study part #2

• Enrolled in study part #1

• Diagnosed with histologically-proven invasive breast cancer

• Prescribed neoadjuvant chemotherapy for breast cancer

Exclusion Criteria:

• Pregnant

• Unable to give written, informed consent.

Related Conditions & MeSH terms

• Breast Neoplasms
• Breast Tumor

Intervention

Device:
• DOSI
Breast tissue properties scanning

Locations

Country	Name	City	State
United States	Pacific Breast Care Clinic	Costa Mesa	California
United States	Beckman Laser Institute University of California Irvine	Irvine	California
United States	University of California, Irvine Medical Center	Irvine	California
United States	University of California San Francisco	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
Beckman Laser Institute and Medical Center	Beckman Laser Institute University of California Irvine, University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of oxy-hemoglobin (HbO2), in blood.		through study completion, an average of 3 years
Primary	Concentration of deoxy-hemoglobin (HHb) in blood.		through study completion, an average of 3 years
Primary	Concentration of total hemoglobin in blood.		through study completion, an average of 3 years
Primary	Water content of tissue (%)		through study completion, an average of 3 years
Primary	Bulk lipid in tissue (%)		through study completion, an average of 3 years