Monitoring and Predicting Breast Cancer Neoadjuvant Chemotherapy Response Using Diffuse Optical Spectroscopic Imaging

Breast Cancer Clinical Trial

Official title:

Monitoring and Predicting Breast Cancer Neoadjuvant Chemotherapy Response Using Diffuse Optical Spectroscopic Imaging

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01257932
• Other study ID #: 20107812
• Status: Withdrawn
• Start date: December 2010
• Est. completion date: October 2013

Study information

• Verified date: October 2022
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Device:
• Diffuse Optical Spectroscopy Imaging
Diffuse Optical Spectroscopy Imaging Breast Cancer Response to Neoadjuvant Chemotherapy

Locations

Country	Name	City	State
United States	Beckman Laser Institute	Irvine	California

Sponsors (9)

Lead Sponsor	Collaborator
University of California, Irvine	American College of Radiology Imaging Network, Beckman Laser Institute University of California Irvine, Boston University, Dartmouth-Hitchcock Medical Center, M.D. Anderson Cancer Center, Massachusetts General Hospital, University of Pennsylvania, University of San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic Tool Breast Cancer Response to Neoadjuvant Chemotherapy	Diffuse Optical Spectroscopy Imaging Breast Cancer Response to Neoadjuvant Chemotherapy	up to 12 months