patient with cito-istologic diagnosis of locally advanced breast cancer MedDRA version: 14.1 Level: SOC Classification code 10029104 Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps) System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: OPTIRAY*EV 10SIR 100ML 300MG/M
Pharmaceutical Form: Concentrate for solution for injection/infusion
INN or Proposed INN: ioversol
CAS Number: 87771-40-2
Concentration unit: mg milligram(s)
Sponsors
AZIENDA OSPEDALIERA ARCISPEDALE S. MARIA NUOVA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a. a diagnosis of breast cancer that will undergo neoadjuvant chemotherapy; b. Over 18 years of age; c. Agreement to undergo the study procedures and to sign the informed consent. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: a. those with a known mutation of the gene BRCA; b. those who cannot undergo MR examinations or for whom it is contraindicated; c. those who are pregnant, demonstrated by blood tests; d. those who have contraindications to the administration of iodine or gadolinium contrast agent (high creatinine value, renal insufficiency) or allergies to the contrast agent. Blood tests including creatinine levels will be performed every three weeks by the Oncology Department.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to compare CE-MRI and CESM in the evaluation of neoadjuvant treatment in patients with locally advanced breast cancer, histopathological evaluation being the gold standard;Secondary Objective: To evaluate the diagnostic performance of both techniques and their agreement will be assessed. An evaluation of the impact of CESM on surgical planning will also be performed;Timepoint(s) of evaluation of this end point: 12 months;Primary end point(s): The parameters that will be evaluated are: - lesion size, defined as the major axis of the lesion according to RECIST criteria (Response Evaluation Criteria in Solid Tumours), compared with the histologic evaluation on the surgical sample as a gold standard; - lesion location in one of the four quadrants (compared with surgical findings); - lesion shape (Fischer’s score as discussed in Girardi W. et al., Radiol. Med. 2010: round, oval, polygonal, linear, dendritic, spiculated); - vascularization (contrast agent uptake; qualitative evaluation of contrast agent uptake [strong, intermediate, weak], and assessment of the kinetics by means of an intensity-time curve; contrast agent uptake pattern: homogeneous, unhomogeneous, septate, rim); - multifocality; - borders (according to Fischer’s score: well or bad defined) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - morphologic and dynamic correlation with histotype; - correlation with ultrasounds and mammography.;Timepoint(s) of evaluation of this end point: 12 months | — |
Countries
Italy
Contacts
Public ContactS.C. di Radiologia
Azienda ospedaliera S. Maria Nuova
Outcome results
None listed