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

NCT ID: NCT01257932

Last Updated: 2022-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2010-12-31

Study Completion Date

2013-10-31

Brief Summary

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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

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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.

Conditions

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Breast Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Diagnostic Tool

Diffuse Optical Spectroscopy Imaging Breast Cancer Response to Neoadjuvant Chemotherapy

Diffuse Optical Spectroscopy Imaging

Intervention Type DEVICE

Diffuse Optical Spectroscopy Imaging Breast Cancer Response to Neoadjuvant Chemotherapy

Interventions

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Diffuse Optical Spectroscopy Imaging

Diffuse Optical Spectroscopy Imaging Breast Cancer Response to Neoadjuvant Chemotherapy

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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American College of Radiology Imaging Network

NETWORK

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role collaborator

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role collaborator

University of San Francisco

OTHER

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role collaborator

Boston University

OTHER

Sponsor Role collaborator

Beckman Laser Institute University of California Irvine

OTHER

Sponsor Role collaborator

University of California, Irvine

OTHER

Sponsor Role lead

Responsible Party

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Beckman Laser Institute and Medical Center

Bruce Tromberg, PhD., Director, Beckman Laser Institute and Medical Clinic, Professor, Departments of Biomedical Engineering and Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bruce Tromberg, PhD

Role: STUDY_DIRECTOR

Beckman Laser Institute

Locations

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Beckman Laser Institute

Irvine, California, United States

Site Status

Countries

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United States

Other Identifiers

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20107812

Identifier Type: -

Identifier Source: org_study_id

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