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

Launched by KAROLINSKA INSTITUTET · Oct 1, 2020

Keywords

ClinConnect Summary

The KARMA Kontrast trial is studying a new method called Contrast Enhanced Mammography to help find breast cancer earlier in women who have already been called back for further testing after a routine mammogram. This trial takes place at Södersjukhuset Breast Centre in Stockholm and aims to see if adding this new imaging technique can help radiologists spot any additional signs of breast cancer compared to standard methods. The trial will also look at any side effects from the contrast used and gather feedback from participants about their experience.

To be eligible, women must be between 25 and 85 years old and have been recalled after an abnormal mammogram or have breast symptoms that need further investigation. Participants will need to sign a consent form to join the study. It’s important to note that some women will not be eligible, including those who have had breast cancer before or have certain medical conditions. If you choose to participate, you can expect to undergo additional imaging tests while helping researchers understand how to improve breast cancer detection.

Gender

FEMALE

Eligibility criteria

• 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