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Contrast kinetics in dynamic contrast-enhanced MRI of the breast in patients with histologically proven breast cancers with and without a computer aided detection system.

Contrast kinetics of Gadobutrol in dynamic contrast-enhanced MRI of the breast in patients with histologically proven breast cancers initially classified as BIRADS 5 with and without a computer aided detection system.

Status
Active, not recruiting
Phases
Unknown
Study type
Unknown
Source
NL-OMON
Registry ID
NL-OMON22751
Enrollment
30
Registered
2014-12-30
Start date
2015-01-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

MRI, CAD, Computer Aided Detection system, breast, Gadobutrol

Interventions

None

Sponsors

Atrium Medisch Centrum Parkstad
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: •At least 18 years of age •Histologically proven breast cancer (BIRADS 5) •Patients who are willing to undergo study procedures

Exclusion criteria

Exclusion criteria: •Patients who have previously entered this study •Patients who are or are suspected in pragnancy or nursery •Patients with a contraindication for MRI •Patients who have received any contrast material within 48 hours prior to injection with study or comparator drug. •Patients who require emergency treatment •Patients with impaired renal function of CKD stadium 3 and higher (e.g. creatinine clearance < 60ml/ min). In patients with known renal impairment, clearance will be calculated based on serum creatinine level using the Cockroft-Gault formula. Calculation of the clearance must be done before begin of study. •Patients with known anaphylactoid or anaphylactic reaction to any contrast media

Design outcomes

Primary

MeasureTime frame
The initial rate of enhancement, the maximum enhancement, and the percentage decrease in enhancement in the signal intensity-time curves measured at the last time point relative to the maximum enhancement within the first 120 seconds post contrast agent administration will be determined with and without the use of the CAD-system.—

Secondary

MeasureTime frame
Interobserver variability with and without the use of the CAD-system will be determined—

Contacts

Public ContactM. Junghans

Postbus 4446

mjs01@atriummc.nl+31 (0)45 5766642

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)