Feasibility study of a non-contrast MRI-scan for breast cancer screening using Velocity Selective Arterial Spin Labeling

Feasibility study of a non-contrast MRI-scan for breast cancer screening using Velocity Selective Arterial Spin Labeling - Non-contrast MRI breast cancer screening

Status

Active, not recruiting

Phases

Phase 2

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON50007

Enrollment

Registered

2020-04-22

Start date

2020-07-02

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

breast cancer

Interventions

All patients participating in the study will undergo a single additional non-invasive MRI scan.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: female patients scheduled for an MR-breast scan patients volunteer to participate and are capable and prepared to sign an informed consent patients of 18 years or older.

Exclusion criteria

Exclusion criteria: patients who would otherwise not an undergo MR-breast scan patients who are not able or willing to comply with breathing instructions patients with contra-indications for Gadolinium-contrast agents patients who underwent breast reduction.

Design outcomes

Primary

Measure	Time frame
As the main study parameter VS-ASL and DCE-MRI scans will be compared on image quality based on visual scoring of three experienced radiologists. The readers will be blinded to original study interpretations.	—

Secondary

Measure	Time frame
As secondary study parameter VS-ASL and DCE-MRI scans will be compared based on quantitative lesion characteristics, e.g. tumor size, relative signal enhancement of tumor, etc, as well as overall suspicion for cancer. In addition, VS-ASL and DCE-MRI outcome will be compared to biopsy results (if available).	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)