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Monitoring and Predicting Breast Cancer Neoadjuvant Chemotherapy Response Using DOSI

This study is currently recruiting participants.
See Contacts and Locations
Verified February 2017 by Beckman Laser Institute and Medical Center, University of California, Irvine
Sponsor:
Collaborators:
Beckman Laser Institute University of California Irvine
University of California, San Francisco
Information provided by (Responsible Party):
Beckman Laser Institute and Medical Center, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT02725658
First received: January 29, 2016
Last updated: February 8, 2017
Last verified: February 2017
  Purpose
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.

Condition Intervention
Breast Tumor Device: DOSI

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Health Services Research
Official Title: Monitoring and Predicting Breast Cancer Neoadjuvant Chemotherapy Response Using Diffuse Optical Spectroscopic Imaging in a Multi-Center Setting

Resource links provided by NLM:


Further study details as provided by Beckman Laser Institute and Medical Center, University of California, Irvine:

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

Estimated Enrollment: 200
Study Start Date: December 2015
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
DOSI Device: DOSI
Breast tissue properties scanning
Other Name: Diffuse Optical Spectroscopy

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.

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02725658

Contacts
Contact: Ata Sharif, MD, MBA 949-824-9265 jehren@uci.edu
Contact: Thomas O'Salivan, PhD 9498248838 tosulliv@uci.edu

Locations
United States, California
Pacific Breast Care Clinic Recruiting
Costa Mesa, California, United States, 92627
Contact: Ata Sharif, MD, MBA    949-824-9265    sharifs@uci.edu   
Sub-Investigator: Freddie Combs, MD         
Principal Investigator: Alice Police, MD         
Beckman Laser Institute University of California Irvine Recruiting
Irvine, California, United States, 92612
Contact: Ata Sharif, MD, MBA    949-824-9265    sharifs@uci.edu   
Principal Investigator: Bruce J Tromberg, PhD         
Sub-Investigator: Thomas O'Salivan, PhD         
Sub-Investigator: Amanda Durkin, BS         
Sub-Investigator: Ylenia Santoro, PhD         
Sub-Investigator: Anais Leproux, PhD         
Sub-Investigator: Brian Hill, MS         
Sub-Investigator: Jennifer Ehren, PhD         
Sub-Investigator: Ata Sharif, MD, MBA         
University of California, Irvine Medical Center Recruiting
Irvine, California, United States, 92612
Contact: Ata Sharif, MD, MBA    949-824-9265    sharifs@uci.edu   
Contact: Thomas O'Salivan, PhD    9498248838      
Sub-Investigator: Karen T Lane, MD         
Sub-Investigator: Rita Mehta, MD         
Sub-Investigator: Chaitali Nangia, MD         
Sub-Investigator: Robert Carroll, MD         
Sub-Investigator: Erin Lin, DO         
University of California San Francisco Recruiting
San Francisco, California, United States, 94110
Contact: Roxana Dhada, SRA    415-885-7506    Roxana.Dhada@ucsf.edu   
Contact: David McCoy    (415) 206-2647    David.Mccoy@ucsf.edu   
Principal Investigator: Nola Hylton, PhD         
Sub-Investigator: Heather Greenwood, MD         
Sub-Investigator: Bonnie Joe, MD, PhD         
Sponsors and Collaborators
Beckman Laser Institute and Medical Center
Beckman Laser Institute University of California Irvine
University of California, San Francisco
Investigators
Principal Investigator: Bruce J Tromberg, PhD Beckman Laser Institute
  More Information

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, University of California, Irvine
ClinicalTrials.gov Identifier: NCT02725658     History of Changes
Other Study ID Numbers: NIH/LAMMP-2015-2355
Study First Received: January 29, 2016
Last Updated: February 8, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Beckman Laser Institute and Medical Center, University of California, Irvine:
Neoadjuvant Therapy
Diffuse Optical Spectroscopic Imaging
DOSI
Neoadjuvant Chemotherapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on June 23, 2017