Clinical trial · Interventional
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
NCT01755130CI-TRIAL-00052464terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): due to lack of funding
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasm | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Inflammatory Breast Carcinoma | Breast Inflammatory Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Photoacoustic Imaging | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (LOUISA 3D)
- 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.
- interventionNames
- Procedure: Photoacoustic Imaging
Primary outcomes (2)
- measure
- Number of images successfully obtained from laser optoacoustic and ultrasonic imaging system assembly (LOUISA) 3-dimensional (3D)
- timeFrame
- Within 7 days of the standard of care ultrasound
- 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.
- measure
- False positive rate of LOUISA 3D and standard of care ultrasound
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.