Clinical trial NCT01257932: Monitoring and Predicting Breast Cancer Neoadjuvant Chemotherapy Response Using Diffuse Optical Spectroscopic Imaging
Official title: Monitoring and Predicting Breast Cancer Neoadjuvant Chemotherapy Response Using 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Overall status: WITHDRAWN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: American College of Radiology Imaging Network
name: Massachusetts General Hospital
name: University of Pennsylvania
name: Dartmouth-Hitchcock Medical Center
name: University of San Francisco
name: M.D. Anderson Cancer Center
name: Boston University
name: Beckman Laser Institute University of California Irvine
First posted: 2010-12-10
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic and community sample

Brief summary: The investigators have developed imaging protocols to monitor and predict breast cancer response to neoadjuvant chemotherapy, both prior to and as early as possible during the course of treatment.

The efficacy and practicality of conventional imaging approaches in the neoadjuvant chemotherapy setting varies and identifies the need for alternate functional imaging strategies. Diffuse optical spectroscopic imaging is an experimental imaging method that allows patients to be followed from baseline through treatment and surgery with a cost-effective, bedside, handheld scanning probe. The researcher evaluates a harmonized diffuse optical spectroscopic imaging technology platform that has been standardized for neoadjuvant chemotherapy monitoring. Diffuse optical spectroscopic imaging is an academic research platform that is non-invasive. Studies will be performed in five clinical sites on approximately 60 neoadjuvant chemotherapy patients.

Detailed description: The investigators are testing the effectiveness of an experimental imaging technology known as Diffuse Optical Spectroscopy Imaging in predicting the success of chemotherapy treatment (shrinkage of tumor).

Diffuse optical spectroscopic imaging measurements are made with a laser breast scanner. This bedside-capable system combines frequency-domain photon migration with steady-state tissue spectroscopy to measure complete(broadband) near-infrared absorption and reduced scattering spectra of breast tissue in vivo. Diffuse Optical Spectroscopy Imaging measurements are made by placing the hand-held probe on the tissue surface and moving the probe to discrete locations along a grid pattern at 1.0 cm intervals. The portable high-bandwidth Frequency-Domain Photon Migration instrument employs intensity-modulated diode lasers and conventional steady-state lamps as sources and an avalanche photodiode as the detector. The time required to perform an Frequency-Domain Photon Migration measurement depends on the desired precision and number of sweeps.

Eligibility criteria: Inclusion Criteria:

* Female, 18 years of age or older, non pregnant or nursing.
* Diagnosis of breast cancer and will be receiving chemo therapy treatments

Exclusion Criteria:

* 18 years of age or younger, pregnant or nursing.
* Previous treatment including chemo therapy, radiation, surgery, and hormone therapy.
* Previous diagnosis with other form of cancer.

Primary outcomes:
measure: Diagnostic Tool Breast Cancer Response to Neoadjuvant Chemotherapy
timeFrame: up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Beckman Laser Institute
state: California
Study officials:
affiliation: Beckman Laser Institute
name: Bruce Tromberg, PhD
role: STUDY_DIRECTOR
References: