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Completed

NCT Number: NCT04579107

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

25 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Bröstcentrum, Södersjukhuset

Stockholm, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Contrast Enhanced Mammography

Combination Product

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Tumor size assessment

    Time frame: 1 day

    Comparing Contrast Enhanced Mammography with each standard breast radiology work-up method for tumor size assessment.

  5. 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.

  6. Contrast Enhanced Mammography costs

    Time frame: 1 day

    Calculate the costs for using Contrast Enhanced Mammography

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Stockholm South General Hospital

Registry information

Official study title

KARMA Kontrast - a Controlled Clinical Trial Evaluating Contrast Enhanced Mammography in Early Detection of Breast Cancer

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Oct 8, 2020
Registry last updated
Aug 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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