DETECTION RATE AND CLASSIFICATION OF BREAST LESIONS WITH DIGITAL MAMMOGRAPHY WITH CONTRAST MEDIUM (CEDM) ALONE AND IN COMBINATION WITH TOMOSYNTHESIS COMPARED TO MR IMAGING WITH GADOLINIUM IN DYNAMICS (DCE-MRI) - CEDM-MRI

IRCCS Istituto Nazionale Tumori Fondazione Pascale1 site in 1 country400 target enrollmentJanuary 8, 2025

DrugsUltravist 370 mg/ml soluzione iniettabile VISIPAQUE 320 mg I/ml soluzione iniettabile OMNIPAQUE 350 mg I/ml soluzione iniettabile

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Not specified
Sponsor: IRCCS Istituto Nazionale Tumori Fondazione Pascale
Enrollment: 400
Locations: 1
Primary Endpoint: Equivalence/Comparability of CEDM alone and in combination with DBT compared to Contrast-Enhanced MRI (CE-MRI) in terms of detection rate and diagnostic accuracy.
Status: Not yet recruiting
Last Updated: 10 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Evaluate, on a large case series, the detection rate and diagnostic accuracy, as well as the extent of breast pathology in terms of multifocality, multicentricity, and bilaterality, of CEDM alone and in combination with tomosynthesis, compared to MRI, considered both as CE-MRI and DCE-MRI.

Registry

euclinicaltrials.eu

Start Date

January 8, 2025

End Date

TBD

Last Updated

10 months ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Investigators

Sponsor

IRCCS Istituto Nazionale Tumori Fondazione Pascale

Responsible Party

Principal Investigator

Antonella Petrillo

Scientific

IRCCS Istituto Nazionale Tumori Fondazione Pascale

Eligibility Criteria

Inclusion Criteria

•Age > 18 years
•Patients with suspected breast pathology or patients in pre-surgical staging for breast pathology already confirmed by conventional imaging (Ultrasound and/or traditional 2D Mammography) or by cytological/histopathological examination
•Full information about the study and signing of the informed consent to participate in the study
•Performance of exams at any time during the menstrual cycle
•Estimated glomerular filtration rate (eGFR) > 60 mL/min/1.73 m², derived from serum creatinine measurement within two weeks prior to enrollment in the study

Exclusion Criteria

•Presence of pacemakers or other devices in the chest wall
•Allergies to iodinated contrast media and/or gadolinium
•Claustrophobia
•Acute renal failure of any severity due to hepatorenal syndrome and/or established in the preoperative period of liver transplantation
•Acute or chronic renal failure, moderate or severe (glomerular filtration rate <60 mL/min/1.73m²)
•Hypersensitivity to the active ingredient of the contrast medium or any of its excipients
•Overt thyrotoxicosis
•Participation in a clinical trial where an investigational drug was administered within 30 days or 5 half-lives of the study drug
•Any clinical condition that, in the investigator's opinion, would render the patient unsuitable for the study
•Presence of breast implants

Outcomes

Primary Outcomes

Equivalence/Comparability of CEDM alone and in combination with DBT compared to Contrast-Enhanced MRI (CE-MRI) in terms of detection rate and diagnostic accuracy.

Secondary Outcomes

Evaluation of the diagnostic accuracy of a radiomic signature of morphological and textural features extracted from the three modalities (CEDM, DBT, and MRI) in the classification of breast lesions in terms of benignity, malignancy, grade, and tumor phenotype (luminal A, luminal B, HER2+, triple negative).