KARMA Kontrast Evaluating Contrast Enhanced Mammography in Early Detection of Breast Cancer

KARMA Kontrast - a Controlled Clinical Trial Evaluating Contrast Enhanced Mammography in Early Detection of Breast Cancer

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.

Inclusion Criteria:

• Female
• 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)

Exclusion Criteria:

• 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