Breast Cancer
Conditions
Keywords
Contrast Enhanced Mammography
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.
Interventions
COMBINATION_PRODUCTContrast 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.
Sponsors
Stockholm South General Hospital
Karolinska Institutet
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
The added Contrast Enhanced Mammography will be evaluated by a radiologist blinded from the radiologists evaluating the standard of care examinations.
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| Contrast Enhanced Mammography costs | 1 day | Calculate the costs for using Contrast Enhanced Mammography |
| Tumor size assessment | 1 day | Comparing Contrast Enhanced Mammography with each standard breast radiology work-up method for tumor size assessment. |
Countries
Sweden
Contacts
Primary ContactMagnus Bäcklund, MD PhD
Backup ContactPer Hall, MD PhD
Outcome results
None listed