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

Not Applicable

Recruiting

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Contrast Enhanced Mammography	Contrast Enhanced Mammography	All included women go through a Contrast Enhanced Mammography added to the standard of care examinations.

Primary Outcome Measures

Name	Time	Method
Sensitivity of Contrast Enhanced Mammography	1 day	Evaluating sensitivity of Contrast Enhanced Mammography in detecting multifocality and/or contralateral breast cancer, compared to standard breast radiology work-up methods.

Secondary Outcome Measures

Name	Time	Method
Specificity of Contrast Enhanced Mammography	1 day	Estimate the specificity of Contrast Enhanced Mammography in detecting absence of breast cancer, compared to standard breast radiology work-up methods.
Contrast Enhanced Mammography costs	1 day	Calculate the costs for using Contrast Enhanced Mammography
Safety of Contrast Enhanced Mammography	30 days	Evaluate the safety of using Contrast Enhanced Mammography, based on adverse event reporting. Potential adverse event will be collected, reported and, if necessary, intervened, on the day for the Contrast Enhanced Mammography and up to 30 days after. All adverse events will be put in to the eCRF.
Mammographic density influence on the performance of Contrast Enhanced Mammography	1 day	Evaluate if mammographic density influences the performance of Contrast Enhanced Mammography compared to standard breast radiology work-up methods.
Patient acceptance of Contrast Enhanced Mammography	30 days	Evaluate the acceptance in patients, based on a questionnaire at the end of the study visit and structured telephone interviews 1-2 weeks after. The answers to the questionnaire is on a 5-grade scale. The interviews will go deeper and summaries of the answers will be put in to the eCRF.
Tumor size assessment	1 day	Comparing Contrast Enhanced Mammography with each standard breast radiology work-up method for tumor size assessment.

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