Clinical trial NCT04579107: KARMA Kontrast Evaluating Contrast Enhanced Mammography in Early Detection of Breast Cancer
Official title: KARMA Kontrast - a Controlled Clinical Trial Evaluating Contrast Enhanced Mammography in Early Detection of Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: Contrast Enhanced Mammography
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Stockholm South General Hospital
First posted: 2020-10-08
Enrollment: 420
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity of Contrast Enhanced Mammography
timeFrame: 1 day
Secondary outcomes:
measure: Specificity of Contrast Enhanced Mammography
timeFrame: 1 day
measure: Safety of Contrast Enhanced Mammography
timeFrame: 30 days
measure: Patient acceptance of Contrast Enhanced Mammography
timeFrame: 30 days
measure: Tumor size assessment
timeFrame: 1 day
measure: Mammographic density influence on the performance of Contrast Enhanced Mammography
timeFrame: 1 day
measure: Contrast Enhanced Mammography costs
timeFrame: 1 day
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Bröstcentrum, Södersjukhuset
Study officials:
affiliation: Karolinska Institutet
name: Per Hall, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: