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Evaluation of Contrast-Enhanced Spectral Mammography Using Iopromide in Women with Suspicious Breast Lesions to Improve Diagnostic Accuracy

Fast replyRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on improving the diagnosis of breast cancer using a special type of mammogram called Contrast-Enhanced Spectral Mammography. This imaging technique uses a contrast solution called iopromide (Ultravist), which is injected into a vein to help create clearer pictures of breast tissue. The purpose is to determine if this enhanced imaging method can better identify suspicious breast lesions and reduce the need for unnecessary tissue sampling procedures.

During the examination, participants will receive an injection of the contrast solution before having their mammogram. The contrast solution helps highlight any abnormal areas in the breast tissue that might indicate the presence of cancer. The imaging procedure is performed in addition to standard breast imaging tests that are normally used in breast cancer diagnosis.

The contrast solution is given through an intravenous injection, with a maximum dose of 740 milligrams per kilogram of body weight. The entire imaging procedure is completed in one day, and the results will be compared with tissue samples to determine how accurate this enhanced mammogram is at identifying breast abnormalities.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial examination
Your participation begins after being identified with a suspicious breast lesion through standard imaging tests (mammogram, ultrasound, or MRI).
The radiological findings must be classified as BI-RADS 4 (suspicious abnormality) to qualify for the next steps.
Step 2
Health status verification
Your overall health status will be evaluated using the ECOG scale. This scale measures your ability to perform daily activities.
You must have an ECOG score of 0 (fully active) or 1 (restricted in strenuous activity but able to carry out light work) to proceed.
Step 3
Contrast-Enhanced Spectral Mammography
You will receive an injection of Ultravist 370 (iopromide) contrast agent through an intravenous line.
A special type of mammogram called Contrast-Enhanced Spectral Mammography (CESM) will be performed to examine the suspicious breast tissue in detail.
Step 4
Biopsy procedure
A vacuum-assisted breast biopsy (VABB) will be performed to collect tissue samples from the suspicious area.
The tissue samples will be examined in the laboratory to determine if cancer cells are present.
Step 5
Results comparison
The results from your CESM examination will be compared with the biopsy results.
If surgery is required based on the findings, the final surgical results will also be compared with the previous imaging results.
Step 6
Study completion
Your participation in the study will end after all examinations and procedures are completed.
The study is expected to continue until April 30, 2026.

Who can join the trial?

5 criteria

Must be a woman aged 18 years or older
Must have suspicious breast lesions detected on previous imaging tests (mammogram, ultrasound, or MRI) that require further evaluation before surgery
Must have breast lesions classified as BI-RADS category 4 (this is a standardized reporting system that indicates a suspicious abnormality with a moderate risk of being cancer)
Must be in good overall health condition to undergo standard imaging tests and Contrast-Enhanced Spectral Mammography (a special type of mammogram that uses contrast dye to better show breast tissue)
Must have good physical function status, specifically an ECOG score of 0 or 1 (meaning either fully active without restrictions or restricted only in physically strenuous activities but able to carry out light work)

Who cannot join the trial?

13 criteria

Pregnancy or suspected pregnancy (due to the use of contrast agents and radiation exposure)
Known severe allergic reactions to iodine-based contrast agents
Severe kidney problems (renal insufficiency) as contrast agents are cleared by the kidneys
Age under 18 years
Male patients (study is designed for female participants only)
Previous severe reactions to any contrast materials used in medical imaging
Uncontrolled hyperthyroidism (overactive thyroid gland)
Active breast infection or inflammation
Recent breast surgery within the past 6 months
Breast implants (may interfere with imaging quality)
Unable to remain still during the examination
Unable to hold breath for short periods when requested
Unable to provide informed consent

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Verified sites

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Istituto Europeo Di Oncologia S.r.l.
Responsive
Milan, Italy

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Investigated drugs

Contrast-Enhanced Spectral Mammography (CESM)
is an advanced imaging technique that uses an iodine-based contrast agent injected into the bloodstream. This technique helps create detailed images of breast tissue by highlighting areas with increased blood flow, which can help identify potential cancerous lesions more accurately than standard mammography.
Vacuum Assisted Breast Biopsy (VABB)
is a minimally invasive procedure used to obtain tissue samples from suspicious areas in the breast. This technique uses a special vacuum-powered device to remove small samples of breast tissue through a tiny incision, allowing doctors to examine the tissue and determine if cancer is present.

Iopromide

What is already known about the treatment

Based on the provided trial data, there is no specific medication to describe, as this is a diagnostic imaging trial using Contrast-Enhanced Spectral Mammography (CESM). This trial focuses on a diagnostic procedure rather than medication. The only substance that might be involved would be the contrast agent used in CESM, but it's not explicitly mentioned in the source data. Without specific information about the contrast agent used, I cannot provide a medication description in the requested format. If you'd like, I can provide information about typical iodinated contrast agents used in CESM procedures, but this would require additional source data to ensure accuracy.

Investigated diseases

Breast Cancer
A disease that begins when cells in the breast tissue start to grow out of control. It typically starts in the ducts that carry milk to the nipple or in the glands that make breast milk. These abnormal cells form a mass or tumor that can be felt as a lump or detected on imaging. The disease can develop over time as cells continue to multiply and spread within the breast tissue. Initially, the cancer may be confined to a small area in the breast, but it can grow larger over time. Breast cancer can occur in both women and men, though it's much more common in women.
Breast Lesions
Abnormal changes in breast tissue that may appear as lumps, masses, or unusual areas visible on breast imaging. These changes can be either benign (non-cancerous) or malignant (cancerous). Breast lesions can vary in size, shape, and characteristics, and may be solid or fluid-filled. They can develop in any part of the breast tissue and may or may not cause noticeable symptoms.