NL-OMON41890已完成不适用
IMAging with opto-acoustics to downgradE BI-RADS claSsificaTion Relative tO other diagnostic methodologies (MAESTRO) - MAESTRO-01
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Subjects must meet all of the following criteria to be included in the study:
- •1. Have been informed of the nature of the study and provided written informed consent, prior to initiation of any study activities;
- •2. Have an undiagnosed suspicious finding which may include more than one solid or complex cystic suspicious mass, classified by CDU as BI-RADS 4a or 4b within 3 weeks of their baseline Imagio Scan;
- •3. Are females 18 years of age or older at the time of consent;
- •4. Are willing and able to complete all procedures and assessments in accordance with the clinical protocol; and,
- •5. Have received recommendation for and are scheduled for an image-guided CNB, DVAB, or excisional biopsy of at least one mass.
- •6. Are willing to have an image-guided CNB, DVAB, or excisional biopsy within 30 days following Imagio evaluation of the breast mass.
排除标准
- •Subjects who meet any of the following criteria will be excluded from the study:
- •1. Are males;
- •2. Are prisoners;
- •3. Have a condition or impediment that could interfere with the intended field of view (within one probe length or 4 cm of the mass), (i.e., breast implants within the previous 12 months, or tattoos);
- •4. Have or have had previously treated (i.e., lumpectomy, partial mastectomy, radiation therapy) cancer in the ipsilateral breast within the same quadrant(s) as the mass(es) to be biopsied;
- •5. Have had prior benign excisional breast biopsy within the immediate vicinity (within one probe length or 4 cm of the mass) of the currently evaluated suspicious mass within the past 18 months.
- •6. Have greater than 3 masses recommended for biopsy at baseline;
- •7. Patient had a previous diagnostic ultrasound of the suspicious mass greater than 3 wekks from the patient*s baseline Imagio scan;
- •8. Have no mass(es) characterized as BI-RADS 4a or 4b as determined by CDU;
- •9. Mass to be biopsied is greater than 3.0 cm in maximum diameter;
- •10. Patient currently has mastitis;
- •11. Patient has focal pain without thickening or mass within one probe length or 4 cm of the mass;
- •12. Is pregnant or lactating or planning to become pregnant during study participation;
- •13. Have open sores including insect bites, rash, poison ivy, and chafing on the skin of the ipsilateral breast within one probe length or 4 cm of the mass;
- •14. Have an acute or a chronic hematoma and/or acute ecchymosis of the ipsilateral breast;
- •15. Is experiencing photo-toxicity or photo-sensitivity or is undergoing treatment for a photo-sensitive condition such as porphyria or lupus erythematosus;
- •16. Patient has received chemotherapy for any type of cancer within 90 days from date of screening CDU;
- •17. Have had previous image guided CNB, image guided DVAB, or surgical biopsy of the target mass of interest;
- •18. Have nipple rings that cannot be removed or are not able to be removed during Imagio OA evaluation or infection or inflammation of the nipple ring area;
- •19. Patient has participated in a clinical study of an investigational drug or device within 3 months prior to screening CDU that may have an impact on clinical outcomes; and,
- •20. Patient has previously participated in this study.
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