KARMA Kontrast - a Controlled Clinical Trial Evaluating Contrast Enhanced Mammography in Early Detection of Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Sensitivity of Contrast Enhanced Mammography
研究概览
简要总结
Women taking part in the National Mammography Screening Program, examined at Södersjukhuset Breast Centre at Södra station in Stockholm and recalled because of suspicion of breast cancer will be invited to participate. A Contrast Enhanced Mammography will be added to the standard of care procedures for investigating a suspicion of breast cancer and blinded from each other 2 radiologists will evaluate either the Contrast Enhanced Mammography or the standard of care examinations. When comparing the potentially extra findings with Contrast Enhanced Mammography will be calculated. Potential side effects together with the patient experience will also be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
The added Contrast Enhanced Mammography will be evaluated by a radiologist blinded from the radiologists evaluating the standard of care examinations.
入排标准
- 年龄范围
- 25 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age: >25 - <85 years
- •Recalled after Mx screening based on abnormal mammographic findings or refered for breast cancer related symtoms
- •The woman has read, understood and signed the Informed Consent Form (ICF)
排除标准
- •Previous breast cancer
- •A breast biopsy performed within 6 weeks preceding the study
- •Recent exposure (during the last week) to iodine contrast media.
- •Pregnancy
- •Current breast feeding
- •Diagnosed with a pheochromocytoma or a paraganglioma
- •Diagnosed with myeloma or other malignant plasma cell disease
- •Diagnosed with myasthenia gravis
- •A renal failure or kidney disorder with increased risk for developing renal failure (single kidney or kidney transplanted)
- •Diabetes (other than dietary treated)
- •Heart failure or liver failure
- •Intake of potentially nephrotoxic substances (daily intake of NSAID, nephrotoxic antibiotics or nephrotoxic chemotherapy)
- •Iodine contrast allergy
- •Uncontrolled thyrotoxicosis
- •A history of severe allergy
- •Subjects unable to read, understand and execute written informed consent
- •Any medical aspect that, according to the investigator, could jeopardize the health of the participant
结局指标
主要结局
Sensitivity of Contrast Enhanced Mammography
时间窗: 1 day
Evaluating sensitivity of Contrast Enhanced Mammography in detecting multifocality and/or contralateral breast cancer, compared to standard breast radiology work-up methods.
次要结局
- Specificity of Contrast Enhanced Mammography(1 day)
- Contrast Enhanced Mammography costs(1 day)
- Safety of Contrast Enhanced Mammography(30 days)
- Mammographic density influence on the performance of Contrast Enhanced Mammography(1 day)
- Patient acceptance of Contrast Enhanced Mammography(30 days)
- Tumor size assessment(1 day)
研究者
Per Hall
Professor
Karolinska Institutet