Expired Study
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Irvine, California 92612


Purpose:

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.


Study summary:

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.


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.


Study is Available At:


Original ID:

NIH-LAMMP-2010-7812


NCT ID:

NCT01257932


Secondary ID:


Study Acronym:


Brief Title:

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


Overall Status:

Withdrawn


Study Phase:

N/A


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of California, Irvine


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:

According to the NIH definition of clinical


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

0


Enrollment Type:

Actual


Overall Contact Information

Official Name:Bruce Tromberg, PhD
Study Director
Beckman Laser Institute

Study Dates

Start Date:December 2010
Completion Date:October 2013
Completion Type:Actual
Primary Completion Date:October 2013
Primary Completion Type:Actual
Verification Date:February 2018
Last Changed Date:February 2, 2018
First Received Date:December 8, 2010

Study Outcomes

Outcome Type:Primary Outcome
Measure:Diagnostic Tool Breast Cancer Response to Neoadjuvant Chemotherapy
Time Frame:up to 12 months
Safety Issues:False
Description:Diffuse Optical Spectroscopy Imaging Breast Cancer Response to Neoadjuvant Chemotherapy

Study Interventions

Intervention Type:Device
Name:Diffuse Optical Spectroscopy Imaging
Description:Diffuse Optical Spectroscopy Imaging Breast Cancer Response to Neoadjuvant Chemotherapy
Arm Name:Diagnostic Tool

Study Arms

Study Arm Type:Other
Arm Name:Diagnostic Tool
Description:Diffuse Optical Spectroscopy Imaging Breast Cancer Response to Neoadjuvant Chemotherapy

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of California, Irvine
Agency Class:Other
Agency Type:Collaborator
Agency Name:American College of Radiology Imaging Network

Samples and Retentions

Study Population: primary care clinic and community sample
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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