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

August 24, 2026 updated by: Per Hall, Karolinska Institutet

KARMA Kontrast - a Controlled Clinical Trial 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden
        • Bröstcentrum, Södersjukhuset

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

36 years to 59 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 day
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.
30 days
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.
30 days
Tumor size assessment
Time Frame: 1 day
Comparing Contrast Enhanced Mammography with each standard breast radiology work-up method for tumor size assessment.
1 day
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.
1 day
Contrast Enhanced Mammography costs
Time Frame: 1 day
Calculate the costs for using Contrast Enhanced Mammography
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Collaborators

Stockholm South General Hospital

Investigators

  • Principal Investigator: Per Hall, MD PhD, Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Actual)

August 31, 2024

Study Completion (Actual)

December 12, 2024

Study Registration Dates

First Submitted

October 1, 2020

First Submitted That Met QC Criteria

October 1, 2020

First Posted (Actual)

October 8, 2020

Study Record Updates

Last Update Posted (Actual)

August 26, 2026

Last Update Submitted That Met QC Criteria

August 24, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KARMA Kontrast

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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