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| Sponsor: | University of California, Irvine |
|---|---|
| Collaborators: |
Beckman Laser Institute University of California Irvine Chao Family Comprehensive Cancer Center Volighten Scientific, Ltd. |
| Information provided by: | University of California, Irvine |
| ClinicalTrials.gov Identifier: | NCT00540852 |
Purpose
At Beckman Laser Institute, University of California, Irvine, the investigators have developed a diagnostic device called 'Photon Migration Spectroscopy'.
Optimal management of patients with locally advanced breast cancer (LABC) remains a complex therapeutic problem. LABC represents 5-20% of all newly diagnosed breast cancers in the United States with a higher incidence in medically underserved areas. Over the years, treatment for LABC has been evolving from undergoing a radical mastectomy to the use of neoadjuvant chemotherapy followed by a mastectomy or breast conservation therapy. The optimal intensity and duration of neoadjuvant chemotherapy for LABC still remains controversial due to the difficulty of evaluating response to therapy. Consequently, it is very important to determine the optimal timing of the local surgical treatment of LABC patients. The goal would be to prevent over and under treatment of patients with neoadjuvant chemotherapy.
PMS is a non-invasive optical technique that utilizes intensity-modulated, near-infrared (NIR) light to quantitatively measure optical properties in thick tissues and has been in use for clinical studies (UCI HS#1995-563). Optical properties (absorption, µa, and scattering, µs', parameters) derived from PMS measurements can be used to construct low-resolution (0.5 -1 cm) functional images of tissue hemoglobin (total, oxy, and deoxy forms), oxygen saturation, blood volume fraction, water content, fat content and cellular structure. Unlike conventional NIR transillumination, PMS enables quantitative analysis of tissue absorption and scattering parameters in a single non-invasive measurement.
The unique functional information provided by PMS makes it well suited for characterizing tumors in thick tissues. Measurements are performed using a non-invasive, multi-wavelength, diode-laser PMS device. Some preliminary results show that the metabolic changes are detectable in locally advanced breast cancer tumors undergoing treatment with neoadjuvant chemotherapy using photon migration techniques. The measurements provide quantitative optical property values that reflect changes in tissue perfusion, oxygen consumption, and cell/matrix development.
| Condition | Intervention |
|---|---|
|
Breast Cancer |
Device: DOS |
| Study Type: | Observational |
| Study Design: | Case-Only, Prospective |
| Official Title: | Monitoring the Response of Chemotherapy on Breast Cancer Tumor by Photon Migration Spectroscopy |
| Estimated Enrollment: | 57 |
| Study Start Date: | June 2002 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Diagnosis
Breast Laser Imaging
|
Device: DOS
Diffuse Optical Spectroscopy
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Non-invasive measurements of breast tissue optical properties will be performed on the skin surface using a specially designed PMS measurement probe which is similar in shape to an ultrasound probe. The PMS probe is embedded with optic fibers set at a fixed separation. The FDPM probe will be placed on different areas of the breast including areas suspected to have disease and areas appearing to be normal. The diseased location will be identified by clinical palpation. Some mild tissue compression will be performed within comfort tolerance of the patient during the application of the PMS probe.
When the probe is in position, the laser will be activated and a measurement will be taken. Each measurement will require about 30-60 seconds to record the data and calculate optical properties. The probe will then be turned off and moved to a new position for further measurements. The process will be repeated until an adequate number of measurements are performed (about 10-20). The whole process should take about 30 to 90 minutes.
Anticipate Risk and Benefit:
The optical scan is not expected to cause any pain, burning, or discomfort during or after the exam. There may be risks, however, that are currently unforeseeable. During all measurements, the laser will be turned on only when needed. Although not required for safety, subjects may wear protective eye goggles if requested.
There is no therapeutic benefit to the subject, especially none that might influence the indication for the diagnostic procedure as indicated. However, information obtained may lead to a new form of non-invasive imaging for the early detection of breast cancer.
Eligibility| Ages Eligible for Study: | 21 Years to 75 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
primary care clinic
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| Beckman Laser Institute University Of California Irvine | |
| Irvine, California, United States, 92612 | |
| Chao Family Comprehensive Cancer Center | |
| Orange, California, United States, 92868 | |
| Principal Investigator: | David Hsiang, M.D | Beckman Laser Institute University of California Irvine |
More Information
| Responsible Party: | Beckman Laser Institute ( David JB Hsiang, M.D ) |
| Study ID Numbers: | LAMMP DOS RR-01192-29., NTROI CA-105480-05 |
| Study First Received: | October 4, 2007 |
| Last Updated: | August 31, 2009 |
| ClinicalTrials.gov Identifier: | NCT00540852 History of Changes |
| Health Authority: | United States: Institutional Review Board |
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Breast cancer receiving chemotherapy |
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Neoplasms Neoplasms by Site Skin Diseases Breast Neoplasms Breast Diseases |
