Clinical trial NCT02725658: Monitoring and Predicting Breast Cancer Neoadjuvant Chemotherapy Response Using DOSI
Official title: Monitoring and Predicting Breast Cancer Neoadjuvant Chemotherapy Response Using Diffuse Optical Spectroscopic Imaging in a Multi-Center Setting
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Breast Tumor
Keywords: Neoadjuvant Therapy
Diffuse Optical Spectroscopic Imaging
DOSI
Neoadjuvant Chemotherapy
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Beckman Laser Institute University of California Irvine
name: University of California, San Francisco
First posted: 2016-04-01
Enrollment: 0
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Concentration of oxy-hemoglobin (HbO2), in blood.
timeFrame: through study completion, an average of 3 years
measure: Concentration of deoxy-hemoglobin (HHb) in blood.
timeFrame: through study completion, an average of 3 years
measure: Concentration of total hemoglobin in blood.
timeFrame: through study completion, an average of 3 years
measure: Water content of tissue (%)
timeFrame: through study completion, an average of 3 years
measure: Bulk lipid in tissue (%)
timeFrame: through study completion, an average of 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Costa Mesa
country: United States
facility: Pacific Breast Care Clinic
state: California
city: Irvine
country: United States
facility: Beckman Laser Institute University of California Irvine
state: California
city: Irvine
country: United States
facility: University of California, Irvine Medical Center
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: Beckman Laser Institute
name: Bruce J Tromberg, PhD
role: PRINCIPAL_INVESTIGATOR
References: