Breast cancer MedDRA version: 14.1 Level: LLT Classification code 10012992 Term: Digital mammography System Organ Class: 10022891 - Investigations
Conditions
Interventions
Trade Name: VISIPAQUE*320MG I/ML FLPP 50ML
Pharmaceutical Form: Solution for injection
INN or Proposed INN: IODIXANOL
CAS Number: 92339112
Current Sponsor code: NA
Other descriptive name: NA
Concentra
Sponsors
ISTITUTO EUROPEO DI ONCOLOGIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Woman diagnosed with breast cancer from FFDM and/or US imaging and for whom a pre-surgical evaluation of extent of disease (including multi-focality) is recommended 2. The subject has dense breasts (BIRADS class 3 or 4 on FFDM) 3. Capable and willing to comply with study procedures, and having signed and dated the informed consent form 4. The subject must have a breast size compatible with the dimensions of the image detector 5. The subject must be in sufficient good health to be able to undergo standard of care and CESM examinations 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 132 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 46
Exclusion criteria
Exclusion criteria: 1. The subject is known to have risks of adverse effects with iodine contrast agents. 2. The subject is asymptomatic and without suspicious findings from routine imaging. 3. The subject has BI-RADS 1, 2 breast density class evaluation from latest mammography. 4. The subject has been previously included in this study. 5. The subject has breasts too large to be adequately positioned on FFDM digital receptor without anatomical cut off during an FFDM examination. 6. The subject is participating in, or has participated (within the prior 30 days) in another clinical trial whit drugs. 7. Has breast implant(s). 8. Has reconstructed breast(s). 9. The subject underwent a prior radiotherapy treatment. 10. The subject is undergoing radiotherapy in the thorax area or chemotherapy. 11. The subject is in such a bad health that she is not able to undergo study examinations. 12. Proved or supposed pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: non-inferiority of CESM versus the combination of FFDM, US and versus MRI in breast lesions detection and characterisation during pre-surgical evaluation of women with dense breasts.;Primary end point(s): • Per case lesion detection sensitivity and specificity from BIRADS for FFDM+US, CESM and MRI pooled across readers scores (threshold for true positive readings = BIRADS 4 - 5) [5] • Performance will be measured using ROC curves.;Timepoint(s) of evaluation of this end point: 18 months;Secondary Objective: Evaluation of detection and characterisation with CESM of breast lesions silent to FFDM but visible with MRI or US. Evaluation in women with dense breasts of CESM assessment method versus the combination of FFDM, US and versus MRI in detection and characterisation of breast lesions, especially for multifocality. CESM sensitivity and specificity comparison versus others imaging methods in multifocal lesions study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Lesion detection sensitivity and specificity from BIRADS scores per reader. • Inter-reader variability on sensitivity and specificity;Timepoint(s) of evaluation of this end point: 18 months | — |
Countries
Italy
Contacts
Public ContactUfficio studi clinici
Istituto Europeo Oncologia
Outcome results
None listed