Rapid access to contrast mammography for women recalled from breast cancer screening

Rapid Access to Contrast-Enhanced spectral mammogRaphy (RACER): a more efficient work-up of women recalled from breast cancer screening

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON22018

Enrollment

528

Registered

2017-07-06

Start date

2017-12-29

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

Breast cancer screening

Interventions

Rapid access to CESM and further work-up of the recalled breast abnormality based on CESM-findings. In CESM, an iodine based contrast agent is injected two minutes prior to image acquisition. Next, st

Eligibility

Inclusion criteria

Inclusion criteria: Included are women able to provide informed consent and recalled from breast cancer screening during the 18-month study period.

Exclusion criteria

Exclusion criteria: Exclusion criteria are contra-indications for the use of iodine-based contrast agents (allergies), severe renal insufficiency or risk for contrast-induced nephropathy

Design outcomes

Primary

Measure	Time frame
Primary diagnostic performance of CESM as compared to mammography, defined as sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV), area under the ROC curve (AUC)	—

Secondary

Measure	Time frame
Days to final diagnosis for both study arms; Patient experienced anxiety (as measured by State-Trait Anxiety Inventory (STAI) and EQ5D questionnaires) for both approaches; cost-effectiveness and budget impact analysis;	—

Contacts

Public ContactM. Lobbes

University Hospital of Maastricht, Department of Radiology, P.O. Box 5800

marc.lobbes@mumc.nl+31 (0)43 3874910

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)