Use of CM in contrast enhanced spectral digital mammography (spectral CEDM, CESM) in the diagnosis of breast pathologies.

Use of CM in contrast enhanced spectral digital mammography (spectral CEDM, CESM) in the diagnosis of breast pathologies. Evaluation of the technique in patients with histologically proven breast cancer and comparison of CESM with MRI.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-002415-26-AT

Enrollment

100

Registered

2012-08-31

Start date

2012-10-01

Completion date

Unknown

Last updated

2022-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Evaluation of CESM in a homogenous, standardized patient population of patients with histologically proven breast cancer who are also planned to receive MRI. Direct comparison of CESM with MRI in terms of reliability. Assessment of discomfort during injection of CM. MedDRA version: 15.0 Level: PT Classification code 10057654 Term: Breast cancer female System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: VISIPAQUE 320 mg J/ml - parenterale Röntgenkontrastmittellösung Product Name: VISIPAQUE 320 mg J/ml - parenterale Röntgenkontrastmittellösung Pharmaceutical Form: Solution for injection/in

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: inormed consent histologically verified malign breast tumour (> 5 mm) 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) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: missing informed consent known contrast media intolerance contra-inications for application of contast media cardiac pacemaker or other MRT contra-indications pregnancy

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluation of CESM in a homogenous, standardized patient population of patients with histologically proven breast cancer who are also planned to receive MRI. Direct comparison of CESM with MRI in terms of reliability. Assessment of discomfort during injection of CM.;Secondary Objective: N.A.;Primary end point(s): N.A.;Timepoint(s) of evaluation of this end point: N.A.	—

Secondary

Measure	Time frame
Secondary end point(s): N.A.;Timepoint(s) of evaluation of this end point: N.A.	—

Countries

Austria

Contacts

Public ContactInvestigator

Medizinische Universität Innsbruck

florian.koppelstaetter@i-med.ac.at+4351250481924

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026