Clinical trial comparing contrast enhanced spectral digital mammography (CESM) and magnetic resonance imaging (MRI) to evaluate the effectiveness of neoadjuvant chemotherapy in patients with locally advanced breast cancer.

• Conditions: MedDRA version: 14.1Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]; patient with cito-istologic diagnosis of locally advanced breast cancer

• Registration Number: EUCTR2012-002784-10-IT
• Lead Sponsor: AZIENDA OSPEDALIERA ARCISPEDALE S. MARIA NUOVA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-26
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified