Breast CancerNCT04579107
KARMA Kontrast Evaluating Contrast Enhanced Mammography in Early Detection of Breast Cancer
A study testing Contrast Enhanced Mammography in people with Breast Cancer, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 85 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Contrast Enhanced Mammography
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSweden
- Study dates
- 1 Oct 2021to 12 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 17Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Breast Cancer
- Being tested
- Contrast Enhanced Mammography
- Keywords
- Contrast Enhanced Mammography
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast Enhanced MammographyCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| Contrast Enhanced Mammography | Other | All included women go through a Contrast Enhanced Mammography added to the standard of care examinations. Receives: Combination Product: Contrast Enhanced Mammography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of Contrast Enhanced Mammography
Evaluating sensitivity of Contrast Enhanced Mammography in detecting multifocality and/or contralateral breast cancer, compared to standard breast radiology work-up methods.
Measured: 1 day
Secondary outcomes (6)
Specificity of Contrast Enhanced Mammography
Estimate the specificity of Contrast Enhanced Mammography in detecting absence of breast cancer, compared to standard breast radiology work-up methods.
Measured: 1 day
Safety of Contrast Enhanced Mammography
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.
Measured: 30 days
Patient acceptance of Contrast Enhanced Mammography
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.
Measured: 30 days
Tumor size assessment
Comparing Contrast Enhanced Mammography with each standard breast radiology work-up method for tumor size assessment.
Measured: 1 day
Mammographic density influence on the performance of Contrast Enhanced Mammography
Evaluate if mammographic density influences the performance of Contrast Enhanced Mammography compared to standard breast radiology work-up methods.
Measured: 1 day
Contrast Enhanced Mammography costs
Calculate the costs for using Contrast Enhanced Mammography
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start1 Oct 2021
- Primary completion31 Aug 2024
- Study completion12 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Stockholm South General Hospital
- Responsible party
- Principal investigator, Per Hall, Karolinska Institutet
- Investigators
- Per Hall, MD PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04579107
- Sponsor's protocol ID
- KARMA Kontrast
- Status last verified
- Aug 2026
- First submitted
- 1 Oct 2020
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KARMA Kontrast - a Controlled Clinical Trial Evaluating Contrast Enhanced Mammography in Early Detection of Breast Cancer
- ClinicalTrials.gov ID
- NCT04579107
- Acronym / sponsor ID
- KARMA Kontrast
- Conditions
- Breast Cancer
- Keywords
- Contrast Enhanced Mammography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Stockholm South General Hospital
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 12 Dec 2024 (actual)
- First posted
- 8 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Contrast Enhanced Mammography | Other | Combination Product: Contrast Enhanced MammographyAll included women go through a Contrast Enhanced Mammography added to the standard of care examinations. |
Who may qualify
- Ages
- 25 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contrast Enhanced MammographyA 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. | Combination product | Contrast Enhanced Mammography |
Primary outcome
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.
6 secondary outcomes
Specificity of Contrast Enhanced Mammography
Time frame: 1 day
Safety of Contrast Enhanced Mammography
Time frame: 30 days
Patient acceptance of Contrast Enhanced Mammography
Time frame: 30 days
Tumor size assessment
Time frame: 1 day
Mammographic density influence on the performance of Contrast Enhanced Mammography
Time frame: 1 day
Contrast Enhanced Mammography costs
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Research group web pageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Per Hall, MD PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contrast Enhanced Mammography in people with Breast Cancer, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of Contrast Enhanced Mammography (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.