IODIXANOL for Breast lesions | Breast pathology

Inclusion criteria

• {"criterion_text":"- Age > 18 years\n- Patients with suspected breast pathology or patients in pre-surgical staging for breast pathology already confirmed by conventional imaging (Ultrasound and/or traditional 2D Mammography) or by cytological/histopathological examination\n- Full information about the study and signing of the informed consent to participate in the study\n- Performance of exams at any time during the menstrual cycle\n- Estimated glomerular filtration rate (eGFR) > 60 mL/min/1.73 m², derived from serum creatinine measurement within two weeks prior to enrollment in the study"}

Exclusion criteria

• {"criterion_text":"- Presence of pacemakers or other devices in the chest wall\n- Allergies to iodinated contrast media and/or gadolinium\n- Claustrophobia\n- Acute renal failure of any severity due to hepatorenal syndrome and/or established in the preoperative period of liver transplantation\n- Acute or chronic renal failure, moderate or severe (glomerular filtration rate <60 mL/min/1.73m²)\n- Hypersensitivity to the active ingredient of the contrast medium or any of its excipients\n- Overt thyrotoxicosis\n- Participation in a clinical trial where an investigational drug was administered within 30 days or 5 half-lives of the study drug\n- Any clinical condition that, in the investigator's opinion, would render the patient unsuitable for the study\n- Presence of breast implants\n- Pregnancy or breastfeeding\n- Inability to remain still during the examination\n- Presence of severe heart disease and pulmonary hypertension\n- Presence of acute brain disorders, history of epilepsy\n- Presence of paraproteinemia (myelomatosis and Waldenström's macroglobulinemia)\n- Presence of pheochromocytoma\n- Presence of hyperthyroidism\n- Inflammatory dermatological diseases (psoriasis, eczema, etc.)\n- Presence of tattoos in the affected area\n- Presence of nipple piercings that cannot be removed\n- Internal/external devices that prevent proper patient positioning\n- Metallic/electronic implants, metal fragments\n- Specific breast morphology that hinders the examination (particularly overly large breasts)\n- Allergies to metals"}

Primary endpoints

• {"endpoint_text":"- Equivalence/Comparability of CEDM alone and in combination with DBT compared to Contrast-Enhanced MRI (CE-MRI) in terms of detection rate and diagnostic accuracy.","definition_or_measurement_approach":"Comparison of detection rate and diagnostic accuracy of imaging modalities (CEDM alone, CEDM combined with DBT) versus CE-MRI/DCE-MRI as reference; measured by detection rate and diagnostic accuracy metrics as described in the main objective."}

Secondary endpoints

• {"endpoint_text":"- Evaluation of the diagnostic accuracy of a radiomic signature of morphological and textural features extracted from the three modalities (CEDM, DBT, and MRI) in the classification of breast lesions in terms of benignity, malignancy, grade, and tumor phenotype (luminal A, luminal B, HER2+, triple negative).","definition_or_measurement_approach":"Assessment of a radiomic signature derived from CEDM, DBT, and MRI imaging features to classify lesions for benignity vs malignancy, tumor grade, and tumor phenotype (luminal A, luminal B, HER2+, triple negative); diagnostic accuracy metrics will be used."}

Italy

Earliest CTIS Part Ii Submission Date

14-10-2024

Latest Decision Or Authorization Date

17-06-2025

Processing Time Days

246

Number Of Sites

1

Number Of Participants

400

Primary sponsor

Full Name

IRCCS Istituto Nazionale Tumori Fondazione Pascale

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy