WOMAN WITH BREAST CANCER MedDRA version: 21.0 Level: LLT Classification code 10006206 Term: Breast carcinoma NOS System Organ Class: 100000004864
Conditions
Interventions
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Product Name: Visipaque
Product Code: Iodixanolo
Pharmaceutical Form: Solution for infusion
Sponsors
ISTITUTO NAZIONALE TUMORI - IRCCS FONDAZIONE PASCALE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a) female b) age> 18 years c) patients in follow-up for breast cancer d) breast recurrence suspicion by traditional imaging e) full information on the study and signed the informed consent to participation in the study f) execution of the exams at any time during the menstrual cycle g) estimated rate of glomerular filtration rate (eGFR)> 60 mL/min/1.73m2, derived from serum creatinine assay within two weeks prior to study entry 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 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
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 skin diseases (psoriasis, eczema, etc.) d) pregnant or lactating e) the presence of tattoos on the affected area f) presence of piercing the nipple that cannot be removed g) internal/external devices that prevent the correct positioning of the patient h) metal / electronic, metal splinters i) the particular shape of the breast that prevents the execution of the examination (in particular breast too large) j) allergies to metals k) allergy to iodinated contrast and / or Gadolinium l) claustrophobia m) acute renal insufficiency of any severity due to the hepatorenal syndrome and / or settled in the pre-operative period for liver transplantation n) acute or chronic renal failure, moderate or severe (glomerular filtration rate <60 mL/min/1.73m2) o) the presence of breast implants Criteria related exclusion a) micro-directed biopsy of ipsilateral breast within three months from the date of enrollment in the study b) needle aspiration in the ipsilateral breast within one month from the date of enrollment in the study c) oral contraceptives or hormonal treatment in the last 90 days d) d) the presence of open wounds or surgical clips
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Aim of the study is to assess the diagnostic performance of imaging obtained with new imaging methods represented by digital mammography (2D) with contrast medium (mdc) - DUAL ENERGY CONTRAST ENHANCED DIGITAL MAMMOGRAPHY - and Tomosynthesis (3D), in comparison of traditional 2D mammography and MRI with contrast medium (gold standard), in the follow-up of women operated for breast cancer, in order to assess the best diagnostic accuracy in the detection of recurrence.;Secondary Objective: To standardize the examination protocol of Dual Energy Contrast Enhanced Digital Mammography with the drafting of new guidelines;Primary end point(s): 1) Superiority of CEDM and combination of CEDM and 3D compared to 2D digital mammography traditional and synthesized. Standards of truth is the result of the histo-pathological examination. 2) Non-inferiority of the combination compared to CEDM and 3D contrast-enhanced MRI (DCE-MRI). Standards of truth is the result of the histo-pathological examination. ;Timepoint(s) of evaluation of this end point: every 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Success in the detection of ipsilateral and/or contralateral recurrences with CEDM, 3D/2D, DCE-MRI in order to assess the performance in terms of sensitivity and positive predictive value for the different proposed strategies. Standards of truth is the result of the histo-pathological examination.; Evaluation of the incremental effectiveness of the various proposed strategies.;Timepoint(s) of evaluation of this end point: every 12 months; every 12 months | — |
Countries
Italy
Contacts
Public ContactSC Radiodiagnostica -degenze
ISTITUTO NAZIONALE TUMORI - IRCCS FONDAZIONE PASCALE
Outcome results
None listed