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Role of contrast enhanced mammography with Iomeprol 400 mgI/ml (Iomeron, Bracco), in the identification of breast cancer: I3-MaC Study
EU CTIS ID: 2024-513251-32-00
What this study is testing
To evaluate the diagnostic efficacy of CEM with Iomeprole 400 mg I/ml (Iomeron®, Bracco) at a dose of 1 mL/Kg in patients with BIRADS 4 or 5 breast lesions.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Inclusion criteria: • Female patients ≥ 35 years of age • Patients who underwent mammography during the 5 weeks prior to enrollment in the study • Patients with a breast lesion requiring further assessment with biopsy ● BIRADS 4 or 5 breast lesion seen at mammography ● Suspicion of malignancy of a lesion seen at ultrasound and not evaluable with mammography • Patients who provide their written informed consent and are willing to comply with protocol requirements
You likely can't join if
- Exclusion criteria: • Renal insufficiency (eGFR below 30 mL/min using the MDRD equation [MDRD=Modification of Diet in Renal Disease]) • Allergy to iodinated contrast agents • BRCA 1 or 2 mutation • Pregnant or lactating females; subjects in post-partum • Severe hypertension (systolic blood pressure >100 under treatment or uncontrolled hypertension with systolic pressure >160 and/or diastolic pressure >90)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.