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

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What is this study about?

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.

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.

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.

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.

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.

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.

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 Study?

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 Study?

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

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	16.11.2020

Trial locations

Investigated drugs:

Iopromide

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.

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.

Trial ID:

2024-517486-16-00

Protocol code:

IEO 960

NCT ID:

NCT06311695

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?