Laser Optoacoustic and Ultrasonic Imaging System Assembly in Finding Changes in Tumors in Patients With Breast Cancer

June 24, 2021 updated by: M.D. Anderson Cancer Center

Multimode Laser Optoacoustic Ultrasonic Tomography System for Breast Cancer Care

This clinical trial studies laser optoacoustic and ultrasonic imaging system assembly in finding changes in tumors in patients with breast cancer. Diagnostic procedures, such as laser optoacoustic and ultrasonic imaging system assembly, may help find and diagnose breast cancer and find out how far the disease has spread.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To successfully obtain images from laser optoacoustic and ultrasonic imaging system assembly (LOUISA) 3-dimensional (3D) and assess pathology in order to guide image calibration and gain knowledge about LOUISA 3D capabilities to detect and differentiate breast tumors.

II. Estimate and compare the false positive rate of LOUISA-3D compared to standard of care ultrasound for detecting breast cancer in year 5 of the study.

SECONDARY OBJECTIVES:

I. Determine optimal scanning parameters by assessing certain machine parameters (e.g. illumination and detection conditions, laser pulse repetition rate, laser ultrasound emission characteristics, type of imaging probe, two-dimensional images vs three-dimensional images, coupling medium characteristics, software and firmware, etc.), anatomical information (speed of sound image, acoustic attenuation image, acoustic scattering image), and functional information (total hemoglobin distribution [THb]/image of angiogenesis density, image of blood oxygen saturation [SO2], and image of water distribution).

OUTLINE:

Patients undergo LOUISA 3D over approximately 30 minutes on the same day or within 7 days of any breast imaging procedure and within 7 days before biopsy.

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • M D Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Mass palpable or nonpalpable
  • Tissue density - all tissue types
  • Menses - any stage of cycle
  • Suspicious breast mass(es) defined by mammography or ultrasound indicating biopsy is needed (biopsy not needed if previous biopsy results are available on target lesion[s])
  • Tumor location - the mammography or ultrasound report should not say that the tumor is in close proximity of chest wall
  • Any tumor type (patients with inflammatory breast cancer may be included)

Exclusion Criteria:

  • Patient is unable or unwilling to give informed consent for any reason
  • Disability (psychiatric, neurological or physical, which precludes examination)
  • Patient has tattoos on the region of interest
  • Overweight over 250 pounds (LB)
  • Very large breast size exceeding 6 inch diameter
  • Patient has body piercing jewelry through the nipple that cannot be removed
  • Patient has had a core or excisional biopsy in the ipsilateral breast within the last 2 weeks (patients with previous fine needle aspirations but no ultrasound evidence of hematoma or post biopsy [bx] change may be included)
  • Patient has inflammatory skin disease (i.e., psoriasis, eczema) or other irritation affecting the breast
  • Patient has any pain or high sensitivity in the breast
  • Currently taking hormonal replacement therapy
  • Non-ambulatory or unable to comply with exam
  • Pregnant (pregnancy test is not required, only as confirmed by patient)
  • Breastfeeding
  • Prior breast treatment for target lesion
  • Previous surgery of the breast in the last 3 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diagnostic (LOUISA 3D)
Patients undergo LOUISA 3D over approximately 30 minutes on the same day or within 7 days of any breast imaging procedure and within 7 days before biopsy.
Procedure: Photoacoustic Imaging
Undergo LOUISA 3D

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of images successfully obtained from laser optoacoustic and ultrasonic imaging system assembly (LOUISA) 3-dimensional (3D)
Time Frame: Within 7 days of the standard of care ultrasound
Pathology will provide useful information including but not limited to type of malignancy, tissue type, and other qualitative information that is necessary for image calibration.
Within 7 days of the standard of care ultrasound
False positive rate of LOUISA 3D and standard of care ultrasound
Time Frame: Within 7 days of the standard of care ultrasound
McNemar's test will be used to compare paired proportions and relative false positive rates.
Within 7 days of the standard of care ultrasound

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Wei Yang, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 13, 2014

Primary Completion (Actual)

June 2, 2021

Study Completion (Actual)

June 2, 2021

Study Registration Dates

First Submitted

December 18, 2012

First Submitted That Met QC Criteria

December 18, 2012

First Posted (Estimate)

December 24, 2012

Study Record Updates

Last Update Posted (Actual)

June 29, 2021

Last Update Submitted That Met QC Criteria

June 24, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-0210 (Other Identifier: M D Anderson Cancer Center)
  • NCI-2014-01243 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • NCI-2013-00149

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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