LOUIS-3D Breast Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by M.D. Anderson Cancer Center
Sponsor:
Collaborator:
TomoWave Laboratories, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01755130
First received: December 18, 2012
Last updated: May 13, 2014
Last verified: May 2014
  Purpose

The goal of this clinical research study is to learn if an imaging device called the Laser Optoacoustic Ultrasonic Imaging System (LOUIS-3D) is effective in detecting and monitoring changes in breast tumors.


Condition Intervention
Breast Cancer
Procedure: LOUIS-3D Imaging Procedure

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Multimode Laser Optoacoustic Ultrasonic Tomography System for Breast Cancer Care

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • LOUIS 3D Capability to Detect and Differentiate Breast Tumors [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    The primary aim of this study is to successfully obtain images from LOUIS 3D and assess pathology in order to guide image calibration and gain knowledge about LOUIS 3D capabilities. 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.


Secondary Outcome Measures:
  • Comparison of False Positive Rate of LOUIS-3D Compared to Ultrasound for Breast Cancer Detection [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Secondary objective is to determine optimal scanning parameters by assessing certain machine parameters (e.g. illumination and detection conditions, laser pulse repetition rate, ultrasound emission characteristics, detection probe, 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). Continuous variables summarized using descriptive statistics such as mean, standard deviation, median and range. Categorical variables tabulated by frequencies and the corresponding percentages.


Estimated Enrollment: 96
Study Start Date: May 2014
Estimated Primary Completion Date: May 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LOUIS-3D Imaging Procedure

Part I Years 1-4: Years 1-4 to develop and calibrate the LOUIS-3D machine. The subject of this project is to successfully obtain diagnostic imaging of breast tumors with new imaging technology, laser Optoacoustic Tomography system.

Part 2 Year 5: Goal of part 2 to estimate and compare the false positive rate of LOUIS-3D compared to standard of care ultrasound. Patients will have had a positive standard of care ultrasound requiring a biopsy (gold standard). The LOUIS-3D images will be obtained within 7 days of the standard of care ultrasound.

Procedure: LOUIS-3D Imaging Procedure
LOUIS-3D imaging procedure either on the same day or within 10 days of a regular scheduled visit for a mammogram, ultrasound, magnetic resonance imaging (MRI) scan, or any other breast imaging procedure, between 1 and 7 days before scheduled biopsy. Results of the LOUIS-3D imaging scans compared with results of other imaging scan(s). Entire LOUIS-3D procedure should take about 30 minutes to complete.
Other Name: x-ray

Detailed Description:

If you agree to take part in this study, you will have the LOUIS-3D imaging procedure either on the same day or within 10 days of a regular scheduled visit for a mammogram, ultrasound, magnetic resonance imaging (MRI) scan, or any other breast imaging procedure, between 1 and 7 days before your scheduled biopsy. The results of the LOUIS-3D imaging scans will be compared with the results of your other imaging scan(s).

For the LOUIS-3D procedure, you will lay down on a specially-designed breast exam table and you will place your breast in a bowl-like imaging cup. The imaging cup will be filled with a gel that will help send signals to the imaging machine.

The procedure will produce 2 types of images. For the first type, the imaging cup will deliver light from a laser that will travel into your breast and tumor. The light is designed to detect acoustic waves which produce an image. Even though all light will be contained in the imaging cup, you will wear laser safety goggles during the procedure.

For the second type of image, the imaging cup will deliver an ultrasound to your breast which will produce an ultrasound image.

During the scans, the imaging cup will rotate around the breast to create 3-dimensional pictures. The scans may be repeated several times. The entire LOUIS-3D procedure should take about 30 minutes to complete.

Length of Study:

You will be off study after the LOUIS-3D imaging procedure is complete.

This is an investigational study. The LOUIS-3D device is not FDA approved or commercially available. The use of the LOUIS-3D device to detect and monitor changes in breast tumors is investigational.

Up to 96 participants will be enrolled in this study. All will be enrolled at MD Anderson.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Mass palpable or nonpalpable
  2. Tissue density - all tissue types
  3. Menses - any stage of cycle
  4. Age between 20-70 inclusive
  5. Breast size within specified size (e.g. B, C or D cup as appropriate per a fitting device)
  6. BIRADS category 4 or 5 as defined based on mammography and breast ultrasound indicating need for biopsy
  7. Tumor location - not in close proximity of chest wall (must be at least 10 mm from the chest wall)
  8. Index tumor size is no more than 2 centimeters
  9. Any tumor type (patients with inflammatory breast cancer may be included).

Exclusion Criteria:

  1. Patient is unable or unwilling to give informed consent for any reason
  2. Disability (psychiatric, neurological or physical, which precludes examination)
  3. Patient has tattoos on the region of interest.
  4. Patient has body piercing jewelry through the nipple that cannot be removed.
  5. Patient has had a core or excisional biopsy in the ipsilateral breast within 3 months (patients with previous fine needle aspirations but no US evidence of hematoma or post bx change may be included).
  6. Patient has inflammatory skin disease (i.e., psoriasis, eczema) affecting the breast.
  7. Currently taking hormonal replacement therapy
  8. Non-ambulatory or unable to comply with exam
  9. Weight in excess of exam table limits of 230 LB
  10. Prior biopsy clips present
  11. Implants present
  12. Pregnancy at 6 weeks or later when position on the stomach is not recommended or difficult (pregnancy test till not be required).
  13. Breastfeeding
  14. Previous breast radiation or surgery
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01755130

Contacts
Contact: Wei Yang, MD 713-563-0127

Locations
United States, Texas
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
TomoWave Laboratories, Inc.
Investigators
Principal Investigator: Wei Yang, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01755130     History of Changes
Other Study ID Numbers: 2012-0210, NCI-2013-00149
Study First Received: December 18, 2012
Last Updated: May 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Breast Cancer
LOUIS-3D
Breast Study
x-ray
Multimode Laser Optoacoustic Ultrasonic Tomography System
Mass palpable or nonpalpable
Breast lesions
Ductal carcinomas
Lobular carcinomas
Fibroadenomas

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 22, 2014