An interventional study of Contrast Enhanced Mammography in Breast Cancer, sponsored by Karolinska Institutet. Completed at 1 site in Sweden. Open to female participants aged 25 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by Karolinska Institutet · Not applicable, Interventional, and Diagnostic
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 300 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Karolinska Institutet is the lead sponsor of 1,113 studies on the registry; 267 are open to participants now.
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Exclusion Criteria:
All included women go through a Contrast Enhanced Mammography added to the standard of care examinations.
Combination Product: Contrast Enhanced Mammography
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.
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
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Karolinska Institutet