Monitoring and Predicting Breast Cancer Neoadjuvant Chemotherapy Response Using DOSI

• Sponsor: Beckman Laser Institute and Medical Center (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT02725658
• Collaborator: Beckman Laser Institute University of California Irvine (Other), University of California, San Francisco (Other)
• Enrollment: 0
• Locations: 4
• Arm: 1
• Duration (Months): 48
• Patients Per Site: 0
• Patients Per Site Per Month: 0

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: N/A
• 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: Dec 1, 2015
• Anticipated Primary Completion Date: Dec 1, 2019
• Anticipated Study Completion Date: Dec 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Concentration of oxy-hemoglobin (HbO2), in blood. [through study completion, an average of 3 years]

2. Concentration of deoxy-hemoglobin (HHb) in blood. [through study completion, an average of 3 years]

3. Concentration of total hemoglobin in blood. [through study completion, an average of 3 years]

4. Water content of tissue (%) [through study completion, an average of 3 years]

5. Bulk lipid in tissue (%) [through study completion, an average of 3 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 80 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Pacific Breast Care Clinic	Costa Mesa	California	United States	92627
2	Beckman Laser Institute University of California Irvine	Irvine	California	United States	92612
3	University of California, Irvine Medical Center	Irvine	California	United States	92612
4	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

• Principal Investigator: Bruce J Tromberg, PhD, Beckman Laser Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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
• Other Study ID Numbers: NIH/LAMMP-2015-2355
• First Posted: Apr 1, 2016
• Last Update Posted: Dec 17, 2018
• Last Verified: Dec 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by 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: Neoadjuvant Therapy; Diffuse Optical Spectroscopic Imaging; DOSI; Neoadjuvant Chemotherapy
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Dec 17, 2018