IOMEPROL for Breast cancer

Inclusion criteria

• {"criterion_text":"- Female patients ≥ 35 years of age\n- Patients who underwent mammography during the 5 weeks prior to enrollment in the study\n- Patients with a breast lesion requiring further assessment with biopsy\n- BIRADS 4 or 5 breast lesion seen at mammography\n- Suspicion of malignancy of a lesion seen at ultrasound and not evaluable with mammography\n- Patients who provide their written informed consent and are willing to comply with protocol requirements"}

Exclusion criteria

• {"criterion_text":"- Renal insufficiency (eGFR below 30 mL/min using the MDRD equation [MDRD=Modification of Diet in Renal Disease])\n- Allergy to iodinated contrast agents\n- BRCA 1 or 2 mutation\n- Pregnant or lactating females; subjects in post-partum\n- Severe hypertension (systolic blood pressure >100 under treatment or uncontrolled hypertension with systolic pressure >160 and/or diastolic pressure >90)"}

Primary endpoints

• {"endpoint_text":"- Dose of contrast administered (mL)\n- Contrast flow rate (mL/s)\n- Creatinine\n- BUN\n- VFG\n- Serum Albumin\n- Na\n- K\n- eGFR","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Pre-CEM mammography and breast ultrasound\n- Follow-up mammography and breast ultrasound, 6 and 12 months after CEM","definition_or_measurement_approach":""}

Italy

Earliest CTIS Part Ii Submission Date

15-04-2024

Latest Decision Or Authorization Date

09-07-2024

Processing Time Days

85

Number Of Sites

3

Number Of Participants

173

Primary sponsor

Full Name

Azienda Ospedaliero-Universitaria Policlinico Umberto I

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy

Third parties

• {"country":"","full_name":"Bracco Suisse SA","duties_or_roles":"Monetary support","organisation_type":""}