Monitoring the Response of Chemotherapy on Breast Cancer Tumor by Photon Migration Spectroscopy (PMS)

This study has been completed.
Sponsor:
Collaborators:
Beckman Laser Institute University of California Irvine
Chao Family Comprehensive Cancer Center
Volighten Scientific, Ltd.
Information provided by (Responsible Party):
Montana Compton, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00540852
First received: October 4, 2007
Last updated: October 28, 2011
Last verified: October 2011
  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: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Monitoring the Response of Chemotherapy on Breast Cancer Tumor by Photon Migration Spectroscopy

Resource links provided by NLM:


Further study details as provided by University of California, Irvine:

Enrollment: 77
Study Start Date: June 2002
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Diagnosis
Breast Laser Imaging
Device: DOS
Diffuse Optical Spectroscopy

Detailed Description:

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
Study Population

primary care clinic

Criteria

Inclusion Criteria:

  • Female non-pregnant and age greater than or equal to 21 years old but less than 75 years old
  • Diagnosed with breast cancer and will be receiving neoadjuvant chemotherapy

Exclusion Criteria:

  • Female pregnant and age less than 21 years old and have no diagnosis of breast cancer
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00540852

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
Sponsors and Collaborators
Montana Compton
Beckman Laser Institute University of California Irvine
Chao Family Comprehensive Cancer Center
Volighten Scientific, Ltd.
Investigators
Principal Investigator: David Hsiang, M.D Beckman Laser Institute University of California Irvine
  More Information

No publications provided

Responsible Party: Montana Compton, Administrative Nurse Research Coordinator Beckman Laser Institute, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00540852     History of Changes
Other Study ID Numbers: NTROI CA-105480-05
Study First Received: October 4, 2007
Last Updated: October 28, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
Breast cancer receiving chemotherapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 29, 2014