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

Withdrawn

• Conditions: Breast Cancer
• Interventions: Device: Diffuse Optical Spectroscopy Imaging

• Registration Number: NCT01257932
• Lead Sponsor: University of California, Irvine

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.

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2010-12-08
• Study First Submitted QC: 2010-12-09
• Study First Posted: 2010-12-10
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-28
• Last Update Posted: 2022-11-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Diagnostic Tool	Diffuse Optical Spectroscopy Imaging	Diffuse Optical Spectroscopy Imaging Breast Cancer Response to Neoadjuvant Chemotherapy

Primary Outcome Measures

Name	Time	Method
Diagnostic Tool Breast Cancer Response to Neoadjuvant Chemotherapy	up to 12 months	Diffuse Optical Spectroscopy Imaging Breast Cancer Response to Neoadjuvant Chemotherapy

Trial Locations

Locations (1)

Beckman Laser Institute; 🇺🇸 Irvine, California, United States