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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
300
A modality for examining breast conditions which is already approved and used but the evaluation of its role in a recalled screening population is limited. Intravenous iodine contrast is given prior to the mammogram.
Bröstcentrum, Södersjukhuset
Stockholm, Sweden
Sensitivity of Contrast Enhanced Mammography
Evaluating sensitivity of Contrast Enhanced Mammography in detecting multifocality and/or contralateral breast cancer, compared to standard breast radiology work-up methods.
Time frame: 1 day
Specificity of Contrast Enhanced Mammography
Estimate the specificity of Contrast Enhanced Mammography in detecting absence of breast cancer, compared to standard breast radiology work-up methods.
Time frame: 1 day
Safety of Contrast Enhanced Mammography
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.
Time frame: 30 days
Patient acceptance of Contrast Enhanced Mammography
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.
Time frame: 30 days
Tumor size assessment
Comparing Contrast Enhanced Mammography with each standard breast radiology work-up method for tumor size assessment.
Time frame: 1 day
Mammographic density influence on the performance of Contrast Enhanced Mammography
Evaluate if mammographic density influences the performance of Contrast Enhanced Mammography compared to standard breast radiology work-up methods.
Time frame: 1 day
Contrast Enhanced Mammography costs
Calculate the costs for using Contrast Enhanced Mammography
Time frame: 1 day
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