KARMA Kontrast - a Controlled Trial Evaluating Contrast Enhanced Mammography in Early Detection of Breast Cancer
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|ClinicalTrials.gov Identifier: NCT04579107|
Recruitment Status : Not yet recruiting
First Posted : October 8, 2020
Last Update Posted : October 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Combination Product: Contrast Enhanced Mammography||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||420 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Masking Description:||The added Contrast Enhanced Mammography will be evaluated by a radiologist blinded from the radiologists evaluating the standard of care examinations.|
|Official Title:||KARMA Kontrast - a Controlled Trial Evaluating Contrast Enhanced Mammography in Early Detection of Breast Cancer|
|Estimated Study Start Date :||November 9, 2020|
|Estimated Primary Completion Date :||March 1, 2022|
|Estimated Study Completion Date :||May 31, 2022|
Contrast Enhanced Mammography
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 [ Time Frame: 1 day ]Evaluating sensitivity of Contrast Enhanced Mammography in detecting multifocality and/or contralateral breast cancer, compared to standard breast radiology work-up methods.
- Specificity of Contrast Enhanced Mammography [ Time Frame: 1 day ]Estimate the specificity of Contrast Enhanced Mammography in detecting absence of breast cancer, compared to standard breast radiology work-up methods.
- Safety of Contrast Enhanced Mammography [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 1 day ]Comparing Contrast Enhanced Mammography with each standard breast radiology work-up method for tumor size assessment.
- Mammographic density influence on the performance of Contrast Enhanced Mammography [ Time Frame: 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 [ Time Frame: 1 day ]Calculate the costs for using Contrast Enhanced Mammography
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04579107
|Contact: Magnus Bäcklund, MD PhDemail@example.com|
|Contact: Per Hall, MD PhD||+46852480000 ext +firstname.lastname@example.org|
|Principal Investigator:||Per Hall, MD PhD||Karolinska Institutet|