Breast souspicious lesions MedDRA version: 21.1 Level: LLT Classification code 10066275 Term: Comedocarcinoma of breast System Organ Class: 100000004864
Conditions
Interventions
Trade Name: VISIPAQUE
Product Name: VISIPAQUE
Product Code: [VISIPAQUE]
Pharmaceutical Form: Solution for injection
INN or Proposed INN: IODIXANOLO
Current Sponsor code: CEDM-MRI
Concentration unit: m
Sponsors
ISTITUTO NAZIONALE TUMORI - IRCCS FONDAZIONE PASCALE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a) age> 18 years b) patients with suspected mammary pathology or patients in pre-surgical staging due to already ascertained breast pathology (conventional ultrasound and / or traditional 2D mammography) or with a cito / pathological examination c) full information on the study and signature of the informed consent to participate in the study d) execution of examinations at any time of the menstrual cycle e) estimated glomerular filtrate rate (eGFR)> 60mL / min / 1.73m2, derived from serum creatinine dosage within two weeks prior to study enrollment Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 358 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 90
Exclusion criteria
Exclusion criteria: Absolute exclusion criteria a) presence of pacemakers or other devices in the chest wall b) inability to maintain an immobile position during the examination c) inflammatory dermatological diseases (psoriasis, eczema, etc.) d) presence of tattoos on the affected area e) presence of nipple piercings that cannot be removed f) internal / external devices that prevent correct patient positioning g) metal / electronic systems, metal splinters h) particular conformation of the breast which prevents the examination from being carried out (in particular breast too large) i) metal allergies j) allergies to iodine and / or gadolinium contrast medium k) claustrophobia l) acute renal failure of any severity due to hepatorenal syndrome and / or established in the pre-operative period after liver transplantation m) acute or chronic, moderate or severe renal failure (glomerular filtration rate <60mL / min / 1.73m2) n) hypersensitivity to the active ingredient of the contrast medium or to any of the excipients (see brochure Visipaque 320) o) Full-blown thyrotoxicosis p) participation in a clinical study in which an experimental drug was administered within 30 days or 5 half-lives of the study drug q) any clinical condition that in the investigator's judgment would make the patient unsuitable for the study r) presence of breast implants s) pregnancy or breastfeeding ** t) presence of severe heart disease and pulmonary hypertension u) presence of acute brain pathologies, history of epilepsy v) presence of paraproteinemia (myelomatosis and Waldenström macroglobulinemia) w) presence of pheochromocytoma x) presence of hyperthyroidism. ** The state of pregnancy was first ascertained from enrollment by means of the dosage of Beta-hCG on the urine (pregnancy test or urinary beta-HCG) or on the blood (plasma beta-hCG). Relative exclusion criteria a) targeted micro-biopsy in the ipsilateral breast within three months from the date of enrollment in the study b) needle drawn into the ipsilateral breast within one month of the study enrollment date c) presence of surgical clips or open wounds
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The study aims to evaluate the detection rate and the diagnostic accuracy, the evaluation of breast pathology in terms of multifocality, multicentricity, bilaterality of the CEDM alone and in combination with the Tomosynthesis with respect to the magnetic resonance considered both CE-MRI that as DCE-MRI.;Secondary Objective: Secondary objective is the evaluation of a radiomic signature of morphological and textile characteristics extracted from the three imaging techniques (CEDM, DBT and MRI) in the classification of breast diseases in terms of benignity, malignancy, grade and tumor phenotype. For magnetic resonance imaging, the dynamic characteristics that can be extracted from the DCE-MRI and the perfusion and diffusion characteristics that can be extracted from the Diffusion Weighted Imaging and Diffusion Kurtosis Imaging methods will also be considered according to the Magnetic Resonance imaging protocol for the valuable functional information content described.;Primary end point(s): Equivalence / Comparability of CEDM alone and in combination of DBT compared to Magnetic Resonance with contrast medium (CE-MRI) in terms of detection rate and diagnostic accuracy. The ability to assess the extent of mammary pathology in terms of multifocality, multicentricity and bilaterality will also be compared. Standard of truth is the outcome of the cyto-histo-pathological examination. Detection time after the outcome of the biotic collection or after the outcome of the histology on the surgically removed sample.;Timepoint(s) of evaluation of this end point: Following biopsy or surgical treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Evaluation of the diagnostic accuracy of a radiomatic signature of morphological and textural features extracted from the three modalities (CEDM, DBT and MRI) in the classification of mammary lesions in terms of benignity, malignancy, grade and tumor phenotype (luminal A, luminal B, HER2 +, triple negative). For MRI, the dynamic features that can be extracted from the DCE-MRI and the perfusion and diffusion features that can be extracted from the Diffusion Weighted Imaging and Diffusion Kurtosis Imaging modes foreseen in the Resonance imaging protocol for the valuable functional information content it contains will also be considered. Standard of truth is the outcome of the cyto-histo-pathological examination. Detection time after the outcome of the biotic collection or after the outcome of the histology on the surgically removed sample.;Timepoint(s) of evaluation of this end point: Following biopsy or surgical treatment | — |
Countries
Italy
Contacts
Public ContactSC RADIODIAGNOSTICA
ISTITUTO NAZIONALE TUMORI - IRCCS FONDAZIONE PASCALE
Outcome results
None listed