Ongoing Clinical Trials for Breast Proliferative Changes
Currently, there is 1 ongoing clinical trial focused on improving the diagnosis of breast proliferative changes. This trial is investigating the use of contrast-enhanced imaging techniques to help identify suspicious breast lesions more accurately and potentially reduce the need for unnecessary tissue sampling procedures.
Clinical trial locations
Evaluation of Contrast-Enhanced Spectral Mammography Using Iopromide in Women with Suspicious Breast Lesions to Improve Diagnostic Accuracy
This trial is being conducted in Italy and focuses on improving the diagnosis of suspicious breast tissue using an advanced imaging technique called Contrast-Enhanced Spectral Mammography. The technique uses a contrast solution called iopromide, marketed as Ultravist, which is injected into a vein to help create clearer and more detailed pictures of breast tissue.
Main goal of the trial: The primary purpose of this study is to determine whether this enhanced imaging method can better identify suspicious breast lesions and potentially reduce the need for unnecessary tissue sampling procedures. The results from the contrast-enhanced mammogram will be compared with tissue samples obtained through biopsy to evaluate how accurate this imaging technique is at detecting abnormalities that might indicate cancer.
Who can participate: This trial is designed for women aged 18 years or older who have suspicious breast lesions that have been detected on previous imaging tests such as mammograms, ultrasounds, or MRI scans. These lesions must be classified as BI-RADS category 4, which indicates a suspicious abnormality with a moderate risk of being cancerous. Participants must be in good overall health and have good physical function, specifically an ECOG score of 0 or 1. This means they should be either fully active without restrictions or only restricted in physically strenuous activities but still able to carry out light work.
Who cannot participate: Several conditions exclude women from participating in this trial. Pregnant women or those who suspect they might be pregnant cannot participate due to the use of contrast agents and radiation exposure. Women with known severe allergic reactions to iodine-based contrast agents or severe kidney problems are also excluded, as the contrast material is cleared by the kidneys. The trial does not include male patients, as it is specifically designed for female participants. Other exclusion factors include previous severe reactions to any contrast materials used in medical imaging, uncontrolled hyperthyroidism, active breast infection or inflammation, recent breast surgery within the past six months, breast implants that may interfere with imaging quality, inability to remain still during the examination or hold breath for short periods when requested, and inability to provide informed consent.
What happens during the trial: Participants will receive an injection of the contrast agent through an intravenous line, with a maximum dose of 740 milligrams per kilogram of body weight. After the injection, a special mammogram called Contrast-Enhanced Spectral Mammography will be performed to examine the suspicious breast tissue in detail. The contrast solution helps highlight any abnormal areas in the breast tissue by showing areas with increased blood flow, which can help identify potential cancerous lesions. Following the imaging, a vacuum-assisted breast biopsy will be performed to collect tissue samples from the suspicious area for laboratory examination. The entire imaging procedure is completed in one day, and the results will be compared with the biopsy findings to determine the accuracy of this enhanced mammogram technique.
Investigational approach: The trial uses Contrast-Enhanced Spectral Mammography, an advanced imaging technique that employs an iodine-based contrast agent injected into the bloodstream. This technique creates detailed images by highlighting areas with increased blood flow. The vacuum-assisted breast biopsy used in this study is a minimally invasive procedure that 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.
Summary
Currently, only one clinical trial is addressing breast proliferative changes, and it is located in Italy. This trial focuses on improving diagnostic accuracy rather than testing new medications. The study specifically targets the use of contrast-enhanced imaging to help doctors better identify suspicious breast lesions and make more informed decisions about whether tissue sampling is necessary. The trial is designed exclusively for women and uses iopromide as the contrast agent to enhance mammography imaging. The study is expected to continue until April 30, 2026, and aims to compare the accuracy of this enhanced imaging technique with traditional biopsy results.