Breast Neoplasm Clinical Trial
Official title:
Multimode Laser Optoacoustic Ultrasonic Tomography System for Breast Cancer Care
Verified date | June 2021 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 9 |
Est. completion date | June 2, 2021 |
Est. primary completion date | June 2, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years to 85 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | M D Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Within 7 days of the standard of care ultrasound | |
Primary | 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. | Within 7 days of the standard of care ultrasound |
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