Monitoring and Predicting Breast Cancer Neoadjuvant Chemotherapy Response Using DOSI

NCT ID: NCT02725658

Last Updated: 2022-11-01

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2019-12-31

Brief 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.

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.

Conditions

Breast Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

DOSI

Group Type: OTHER

DOSI

Intervention Type: DEVICE

Breast tissue properties scanning

Interventions

DOSI

Breast tissue properties scanning

Intervention Type: DEVICE

Other Intervention Names

Diffuse Optical Spectroscopy

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Beckman Laser Institute University of California Irvine

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: collaborator

Beckman Laser Institute and Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Beckman Laser Institute and Medical Center

Bruce Tromberg, PhD, Director Beckman Laser Institute and Medical Clinic, Professor, Departments of Biomedical Engineering and Surgery

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Bruce J Tromberg, PhD

Role: PRINCIPAL_INVESTIGATOR

Beckman Laser Institute

Locations

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, United States

Countries

United States

Other Identifiers

20152355

Identifier Type: -

Identifier Source: org_study_id