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Monitoring and Predicting Breast Cancer Neoadjuvant Chemotherapy Response Using DOSI

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ClinicalTrials.gov Identifier: NCT02725658
Recruitment Status : Withdrawn (This study doesn't meet NIH criteria of clinical trial study)
First Posted : April 1, 2016
Last Update Posted : December 17, 2018
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

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.

Condition or disease Intervention/treatment Phase
Breast Tumor Device: DOSI Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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
Study Start Date : December 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
DOSI Device: DOSI
Breast tissue properties scanning
Other Name: Diffuse Optical Spectroscopy




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


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02725658


Locations
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United States, California
Pacific Breast Care Clinic
Costa Mesa, California, United States, 92627
Beckman Laser Institute University of California Irvine
Irvine, California, United States, 92612
University of California, Irvine Medical Center
Irvine, California, United States, 92612
University of California San Francisco
San Francisco, California, United States, 94110
Sponsors and Collaborators
Beckman Laser Institute and Medical Center
Beckman Laser Institute University of California Irvine
University of California, San Francisco
Investigators
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Principal Investigator: Bruce J Tromberg, PhD Beckman Laser Institute

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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
First Posted: April 1, 2016    Key Record Dates
Last Update Posted: December 17, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
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:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases