Clinical trial NCT01277263: Predicting Pathological Response Within the 1st Week of Chemotherapy Using Diffuse Optical Spectroscopic Imaging
Official title: Predicting Pathological Response Within the 1st Week of Neoadjuvant Chemotherapy Using Functional Parameters Measured With Diffuse Optical Spectroscopic Imaging
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Breast Cancer
Keywords: Breast Cancer
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Beckman Laser Institute University of California Irvine
First posted: 2011-01-14
Enrollment: 0
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population will be selected from an outpatient population of the Cancer Center Clinic, Beckman Laser Medical Clinic of University of California, Irvine and UCI Pacific Breast Care. Subjects with the requisite diagnosis of breast cancer will be candidates for enrollment.

Brief summary: Women with Breast Cancer who do not respond to chemotherapy may undergo months of treatment with little or no change in tumor size or overall outcome.

The Researchers have demonstrated a previously undescribed "metabolic flare" response observed very early in neoadjuvant treatment in breast cancer patients. The research can determine that this flare is predictive of overall therapy response and is due to both an inflammatory reaction and cell death induced by cytotoxic therapy.

Detailed description: The researcher can use Diffuse Optical Spectroscopic Imaging device to measure and predict the markers of the response in the first weeks of chemo-therapy.

The oxyhemoglobin flare response can predictive of overall pathological response to chemotherapy in human subjects. These vascular changes can indicate the rapid transient increase and then decrease in oxyhemoglobin concentration in the first hours and days after therapeutic administration. The magnitude and time course of the flare response in patients receiving cytotoxic therapy will differ between pathological responders and non-responders. This oxyhemoglobin "flare response" can be observed In tumors where vascular dynamics are intact.

Eligibility criteria: Inclusion Criteria:

* Female, not pregnant, not breastfeeding
* greater than 21 years of age but less than 75 years of age
* will be receiving neoadjuvant chemotherapy for breast cancer as prescribed by their oncologist

Exclusion Criteria:

* Under 21 year of age
* Female pregnant or breastfeeding

Primary outcomes:
measure: improve treatment prognosis for breast cancer patients
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Costa Mesa
country: United States
facility: Pacific Breast Care Medical Clinic
state: California
city: Irvine
country: United States
facility: Beckman Laser Institute
state: California
city: Orange
country: United States
facility: Chao Family Comprehensive Cancer Center, UCIMC
state: California
Study officials:
affiliation: Beckman Laser Institute
name: Bruce Tromberg, PhD
role: STUDY_DIRECTOR
References: