Clinical Trials Directory

Trials / Terminated

TerminatedNCT01755130

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

Multimode Laser Optoacoustic Ultrasonic Tomography System for Breast Cancer Care

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
9 (actual)
Sponsor
M.D. Anderson Cancer Center · Academic / Other
Sex
Female
Age
20 Years – 85 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREPhotoacoustic ImagingUndergo LOUISA 3D

Timeline

Start date
2014-05-13
Primary completion
2021-06-02
Completion
2021-06-02
First posted
2012-12-24
Last updated
2021-06-29

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01755130. Inclusion in this directory is not an endorsement.