2024-519017-62-00招募中2 期
DETECTION RATE AND CLASSIFICATION OF BREAST LESIONS WITH DIGITAL MAMMOGRAPHY WITH CONTRAST MEDIUM (CEDM) ALONE AND IN COMBINATION WITH TOMOSYNTHESIS COMPARED TO MR IMAGING WITH GADOLINIUM IN DYNAMICS (DCE-MRI) - CEDM-MRI
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Equivalence/Comparability of CEDM alone and in combination with DBT compared to Contrast-Enhanced MRI (CE-MRI) in terms of detection rate and diagnostic accuracy.
研究概览
简要总结
Evaluate, on a large case series, the detection rate and diagnostic accuracy, as well as the extent of breast pathology in terms of multifocality, multicentricity, and bilaterality, of CEDM alone and in combination with tomosynthesis, compared to MRI, considered both as CE-MRI and DCE-MRI.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age > 18 years
- •Patients with suspected breast pathology or patients in pre-surgical staging for breast pathology already confirmed by conventional imaging (Ultrasound and/or traditional 2D Mammography) or by cytological/histopathological examination
- •Full information about the study and signing of the informed consent to participate in the study
- •Performance of exams at any time during the menstrual cycle
- •Estimated glomerular filtration rate (eGFR) > 60 mL/min/1.73 m², derived from serum creatinine measurement within two weeks prior to enrollment in the study
排除标准
- •Presence of pacemakers or other devices in the chest wall
- •Allergies to iodinated contrast media and/or gadolinium
- •Claustrophobia
- •Acute renal failure of any severity due to hepatorenal syndrome and/or established in the preoperative period of liver transplantation
- •Acute or chronic renal failure, moderate or severe (glomerular filtration rate <60 mL/min/1.73m²)
- •Hypersensitivity to the active ingredient of the contrast medium or any of its excipients
- •Overt thyrotoxicosis
- •Participation in a clinical trial where an investigational drug was administered within 30 days or 5 half-lives of the study drug
- •Any clinical condition that, in the investigator's opinion, would render the patient unsuitable for the study
- •Presence of breast implants
- •Pregnancy or breastfeeding
- •Inability to remain still during the examination
- •Presence of severe heart disease and pulmonary hypertension
- •Presence of acute brain disorders, history of epilepsy
- •Presence of paraproteinemia (myelomatosis and Waldenström's macroglobulinemia)
- •Presence of pheochromocytoma
- •Presence of hyperthyroidism
- •Inflammatory dermatological diseases (psoriasis, eczema, etc.)
- •Presence of tattoos in the affected area
- •Presence of nipple piercings that cannot be removed
- •Internal/external devices that prevent proper patient positioning
- •Metallic/electronic implants, metal fragments
- •Specific breast morphology that hinders the examination (particularly overly large breasts)
- •Allergies to metals
结局指标
主要结局
Equivalence/Comparability of CEDM alone and in combination with DBT compared to Contrast-Enhanced MRI (CE-MRI) in terms of detection rate and diagnostic accuracy.
Equivalence/Comparability of CEDM alone and in combination with DBT compared to Contrast-Enhanced MRI (CE-MRI) in terms of detection rate and diagnostic accuracy.
次要结局
- Evaluation of the diagnostic accuracy of a radiomic signature of morphological and textural features extracted from the three modalities (CEDM, DBT, and MRI) in the classification of breast lesions in terms of benignity, malignancy, grade, and tumor phenotype (luminal A, luminal B, HER2+, triple negative).
研究者
Antonella Petrillo
Scientific
IRCCS Istituto Nazionale Tumori Fondazione Pascale
研究点 (1)
Loading locations...
相似试验
招募中
不适用
The assessment of lesion detection capability and FDG uptake value by digital PET/CTMalignancy, vasculitis, cardiac sarcoidosis, etc.JPRN-UMIN000040015Ehime University200
已完成
不适用
Detectability of breast lesions of dense breast using low-dose computed tomographyBreast lesionsJPRN-UMIN000029145Hokkaido University80
已完成
不适用
Assessment of breast lesion size and characterization: correlation of cone-beam breast-CT, digital breast tomosynthesis, full-field digital mammography with histopathological examination of mastectomy specimensC50Malignant neoplasm of breastDRKS00012625niversity Medical Center Goettingen40
尚未招募
Unknown
Verification of the performance of lesion detection assistance in computer aided diagnosis endoscopyPatients who underwent computer aided diagnosis endoscopy at our facility and polyps were detectedJPRN-UMIN000053310Oita University50
尚未招募
Unknown
Multicentric study on outcome of treatment of osteosarcoma in India, conducted by Indian Musculo Skeletal Oncology SocietyCTRI/2023/05/053100Indian Musculo Skeletal Oncology Society (IMSOS)