IOPROMIDE for Breast lesions | Breast cancer

Inclusion criteria

• {"criterion_text":"- Woman with suspicious breast lesions from FFDM, US and/or MR imaging and for whom a presurgical evaluation is recommended. Only women in the BI-RADS 4 radiological category risk will be included in the study.\n- The subject must be in sufficient good health to be able to undergo standard of care and CESM examinations. Only patients with ECOG scale 0 or 1 performance status will be included in the study.\n- Only patients with an age > or = to 18 can be included in the study."}

Exclusion criteria

• {"criterion_text":"- The subject is known to have risks of adverse effects with iodine contrast agents.\n- Patients with a clinical examination positive for regional lymph nodes or suspected for distant metastases (bones, brain, liver and lungs).\n- The subject is asymptomatic and without suspicious findings from routine imaging.\n- The subject is participating or has participated (within the prior 30 days) in another clinical trial.\n- Proved or supposed pregnancy. For all women of child bearing potential a pregnancy test will be performed before undergoing CESM.\n- Patients with impairment of renal function (GFR < 30 ml/min).\n- History of bronchial asthma or other allergic disorders.\n- Manifest hyperthyroidism. Testing of thyroid function prior to Ultravist® administration will be performed in patients with suspected hyperthyroidism.\n- Patients with risk of serious adverse reactions such as cardiac disease, heart failure, uncontrolled arterial hypertension.\n- Patients in therapy with biguanide such as metformin, interleukine 2 and radioactive iodine."}

Primary endpoints

• {"endpoint_text":"- To evaluate the negative predictive value (NPV) of CESM comparison versus the NPV of the micro-histology or final histology (after surgery)","definition_or_measurement_approach":"Comparison of CESM negative predictive value versus micro-histology or final histology after surgery (histology used as reference standard)."}

Secondary endpoints

• {"endpoint_text":"- To establish CESM diagnostic performance in suspicious breast lesions using histology from VABB as gold standard correlating the definite result (after surgery) with preoperative imaging (accuracy).","definition_or_measurement_approach":"Diagnostic performance of CESM using histology from VABB as the gold standard and correlating with definitive surgical histology and preoperative imaging (accuracy metrics)."}

Italy

Latest Decision Or Authorization Date

14-10-2024

Number Of Sites

1

Number Of Participants

468

Primary sponsor

Full Name

Istituto Europeo Di Oncologia S.r.l.

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy

Third parties

• {"country":"","full_name":"Ministero della Salute - Bando ricerca finalizzata 2021 - GR-2021-12372179","duties_or_roles":"Source of monetary support","organisation_type":""}