KARMA Kontrast Evaluating Contrast Enhanced Mammography in Early Detection of Breast Cancer

Karolinska Institute

Status: Enrolling

Conditions: Breast Cancer

Treatments: Combination Product: Contrast Enhanced Mammography

Study type: Interventional

Funder types: Other

Identifiers

NCT04579107

KARMA Kontrast

Details and patient eligibility

About

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.

Enrollment: 420 estimated patients

Sex: Female

Ages: 25 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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420 participants in 1 patient group

Contrast Enhanced Mammography

Other group

Description:

All included women go through a Contrast Enhanced Mammography added to the standard of care examinations.

Treatment:

Combination Product: Contrast Enhanced Mammography