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Can a Contrast-Enhanced mammogram spot hidden breast cancers?

NCT ID NCT04579107

Diagnosis Sponsor: Karolinska Institutet Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 26, 2026 · Last updated Aug 27, 2026 · Updated 1 time

Summary

This trial is testing whether contrast enhanced mammography (CEM) can find additional breast cancers that standard imaging might miss in women already recalled for further testing after a screening mammogram. Women with a suspicious finding will receive an extra CEM scan alongside the usual work-up, and two radiologists will independently review the images without knowing which test was used. The study will compare how often CEM detects multiple tumors in the same breast or cancer in the opposite breast, and will also assess side effects and patient comfort.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Contrast enhanced mammography, an imaging technique that uses an intravenous iodine contrast agent before a mammogram
What this could lead to
If successful, this could improve early detection of additional breast cancers, potentially reducing the need for repeat procedures and improving treatment planning.
What could go wrong
The trial is relatively small and early-stage, and the added contrast carries risks such as allergic reactions or kidney strain. The technique may not prove more accurate than standard work-up in all cases.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

300 people

The number who actually took part.

Started

Oct 2021

Finished

Dec 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

25 to 85 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

Contacts and locations

Locations

  • Bröstcentrum, Södersjukhuset

    Stockholm, Sweden

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