KARMA Kontrast Evaluating Contrast Enhanced Mammography in Early Detection of Breast Cancer
NCT ID: NCT04579107
Last Updated: 2023-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
420 participants
INTERVENTIONAL
2021-10-01
2024-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Contrast Enhanced Mammography
All included women go through a Contrast Enhanced Mammography added to the standard of care examinations.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
25 Years
85 Years
FEMALE
No
Sponsors
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Stockholm South General Hospital
OTHER
Karolinska Institutet
OTHER
Responsible Party
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Per Hall
Professor
Principal Investigators
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Per Hall, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institutet
Locations
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Bröstcentrum, Södersjukhuset
Stockholm, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Magnus Bäcklund, MD
Role: primary
Related Links
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Research group web page
Other Identifiers
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KARMA Kontrast
Identifier Type: -
Identifier Source: org_study_id
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