Monitoring and Predicting Breast Cancer Neoadjuvant Chemotherapy Response Using DOSI

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Breast Tumor
• Intervention / Treatment: Device: DOSI

Detailed 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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Costa Mesa, California, United States, 92627
      • Pacific Breast Care Clinic
    • Irvine, California, United States, 92612
      • Beckman Laser Institute University of California Irvine
    • Irvine, California, United States, 92612
      • University of California, Irvine Medical Center
    • San Francisco, California, United States, 94110
      • University of California San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: DOSI	Device: DOSI; Breast tissue properties scanning; Other Names: Diffuse Optical Spectroscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Concentration of oxy-hemoglobin (HbO2), in blood.	through study completion, an average of 3 years
Concentration of deoxy-hemoglobin (HHb) in blood.	through study completion, an average of 3 years
Concentration of total hemoglobin in blood.	through study completion, an average of 3 years
Water content of tissue (%)	through study completion, an average of 3 years
Bulk lipid in tissue (%)	through study completion, an average of 3 years

Collaborators and Investigators

• Sponsor: Beckman Laser Institute and Medical Center
• Collaborators: University of California, San Francisco; Beckman Laser Institute University of California Irvine
• Investigators: Principal Investigator: Bruce J Tromberg, PhD, Beckman Laser Institute

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: January 29, 2016
• First Submitted That Met QC Criteria: March 28, 2016
• First Posted (Estimate): April 1, 2016

Study Record Updates

• Last Update Posted (Actual): November 1, 2022
• Last Update Submitted That Met QC Criteria: October 28, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Neoadjuvant Therapy; Neoadjuvant Chemotherapy; Diffuse Optical Spectroscopic Imaging; DOSI
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 20152355

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO