Laser Optoacoustic and Ultrasonic Imaging System Assembly in Finding Changes in Tumors in Patients With Breast Cancer
Primary Purpose
Breast Neoplasm, Inflammatory Breast Carcinoma
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Photoacoustic Imaging
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Neoplasm
Eligibility Criteria
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
Sites / Locations
- M D Anderson Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Diagnostic (LOUISA 3D)
Arm Description
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.
Outcomes
Primary Outcome Measures
Number of images successfully obtained from laser optoacoustic and ultrasonic imaging system assembly (LOUISA) 3-dimensional (3D)
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.
False positive rate of LOUISA 3D and standard of care ultrasound
McNemar's test will be used to compare paired proportions and relative false positive rates.
Secondary Outcome Measures
Full Information
NCT ID
NCT01755130
First Posted
December 18, 2012
Last Updated
June 24, 2021
Sponsor
M.D. Anderson Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT01755130
Brief Title
Laser Optoacoustic and Ultrasonic Imaging System Assembly in Finding Changes in Tumors in Patients With Breast Cancer
Official Title
Multimode Laser Optoacoustic Ultrasonic Tomography System for Breast Cancer Care
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Terminated
Why Stopped
due to lack of funding
Study Start Date
May 13, 2014 (Actual)
Primary Completion Date
June 2, 2021 (Actual)
Study Completion Date
June 2, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasm, Inflammatory Breast Carcinoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diagnostic (LOUISA 3D)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Photoacoustic Imaging
Intervention Description
Undergo LOUISA 3D
Primary Outcome Measure Information:
Title
Number of images successfully obtained from laser optoacoustic and ultrasonic imaging system assembly (LOUISA) 3-dimensional (3D)
Description
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.
Time Frame
Within 7 days of the standard of care ultrasound
Title
False positive rate of LOUISA 3D and standard of care ultrasound
Description
McNemar's test will be used to compare paired proportions and relative false positive rates.
Time Frame
Within 7 days of the standard of care ultrasound
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Yang
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mdanderson.org
Description
University of Texas MD Anderson Cancer Center Website
Learn more about this trial
Laser Optoacoustic and Ultrasonic Imaging System Assembly in Finding Changes in Tumors in Patients With Breast Cancer
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