Evaluation of Contrast-Enhanced Mammography Using Iomeprol for Diagnostic Efficacy in Patients with BIRADS 4 or 5 Breast Lesions

The primary objective of this study is to evaluate the **diagnostic efficacy** of contrast-enhanced mammography (CEM) using Iomeprol 400 mg I/ml (Iomeron®, Bracco) at a dose of 1 mL/Kg in patients presenting with BIRADS 4 or 5 breast lesions. This is clinically relevant as it aims to enhance the accuracy of breast cancer detection, potentially leading to improved patient outcomes through earlier and more precise diagnosis.

Secondary objectives include:

• To evaluate the quality of CEM images obtained with reduced volumes of a high-concentration contrast agent.

The clinical trial focuses on evaluating the diagnostic efficacy of CEM with Iomeprole 400 mg I/ml in patients with **breast cancer**. The study population consists exclusively of female participants aged 35 years and older. Participants are required to have undergone mammography within the five weeks prior to enrollment and must present with a breast lesion necessitating further assessment via biopsy, specifically those classified as BIRADS 4 or 5. The trial does not include male subjects or vulnerable populations. The sponsor has not provided information regarding the total number of participants. Participants must have provided written informed consent and be willing to comply with protocol requirements. No specific lifestyle considerations such as diet or physical activity are mentioned as part of the selection criteria.

The clinical trial is designed to evaluate the **diagnostic efficacy** of contrast-enhanced mammography (CEM) using **Iomeprol** 400 mgI/ml in patients with BIRADS 4 or 5 breast lesions. This is a Phase IV, randomized, double-blind, controlled trial focusing on adult female patients aged 35 years and older who have undergone mammography within the five weeks prior to enrollment and present with breast lesions requiring further assessment. The trial aims to assess the effectiveness of Iomeprol in identifying breast cancer, with the primary endpoints including the dose of contrast administered, contrast flow rate, and various biochemical parameters such as creatinine and eGFR.

The trial is expected to commence recruitment on May 2, 2024, and conclude by April 30, 2025. Participants will be involved in the study for a maximum treatment period of one day, with the administration of Iomeprol via injection. The study visits will include an initial screening visit to confirm eligibility based on the inclusion criteria, which require written informed consent and willingness to comply with protocol requirements. Follow-up visits will occur at 6 and 12 months post-CEM to conduct mammography and breast ultrasound assessments. The end-of-study visit will mark the completion of the participant's involvement in the trial.

Participants may be subject to early termination from the study if they fail to adhere to the protocol requirements or if any adverse events necessitate withdrawal for safety reasons. The trial's design ensures rigorous control and blinding to maintain the integrity of the data collected. The study will not include any pediatric formulations, and the maximum daily and total dose of Iomeprol is set at 120 ml. The trial's findings are anticipated to contribute significantly to the understanding of CEM's role in breast cancer diagnosis.

The clinical trial involves the use of **Iomeprol**, a chemical substance, as the experimental medication. **Iomeprol** is administered in the form of an injection, with a pharmaceutical form code of PHF00231MIG. The active substance is utilized in the diagnostic technique of Contrast Enhanced Mammography (CEM) to identify breast cancer. The specific formulation used in this study is Iomeprol 400 mgI/ml, commercially known as Iomeron, produced by Bracco. The dosage is calculated at 1 mL per kilogram of body weight, with a maximum daily and total dose of 120 mL. The administration is conducted via injection, and the treatment period is limited to a single day.

No non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatments, are employed in this study. The focus is solely on evaluating the diagnostic efficacy of CEM with Iomeprol in patients presenting with BIRADS 4 or 5 breast lesions. Participant compliance with the dosing schedule is monitored to ensure adherence to the protocol. The trial does not involve any pediatric formulations, and the product is not classified as an orphan drug. The study aims to provide insights into the effectiveness of Iomeprol in enhancing mammographic imaging for the detection of breast cancer.

The clinical trial aims to evaluate the diagnostic efficacy of Contrast Enhanced Mammography (CEM) using **Iomeprol** 400 mg I/ml (Iomeron, Bracco) in patients with BIRADS 4 or 5 breast lesions. Efficacy will be assessed through both primary and secondary endpoints. The primary endpoints include the evaluation of parameters such as the dose of contrast administered (mL), contrast flow rate (mL/s), and various laboratory measures including Creatinine, Blood Urea Nitrogen (BUN), Glomerular Filtration Rate (VFG), Serum Albumin, Sodium (Na), Potassium (K), and estimated Glomerular Filtration Rate (eGFR). These parameters will be measured using standard laboratory tests to ensure accuracy and reliability.

Secondary endpoints involve imaging assessments, including pre-CEM mammography and breast ultrasound, as well as follow-up mammography and breast ultrasound conducted at 6 and 12 months post-CEM. These imaging assessments will be used to monitor changes in breast lesions over time. The trial is designed to collect data at specified timepoints to facilitate a comprehensive analysis of the efficacy of CEM with Iomeprol in identifying breast cancer. The data collected will be analyzed to determine the diagnostic value of the CEM technique in the specified patient population.