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

In breast cancer, patients benefit greatly from early stage detection; 5-year
survival rate is 90% for patients with early-stage detection and 15% for women
with detection at most advanced stage of disease. Dynamic contrast enhanced
(DCE) MRI has proven to increase sensitivity for breast cancer detection
compared to mammography alone, and is currently the standard method for
screening of women with an increased risk of developing breast cancer, e.g.
women with a BRCA-gene mutation. DCE-MRI scans rely on intravenous
administration of gadolinium (Gd)-contrast, which is associated with gadolinium
retention and nephrogenic systemic fibrosis. However, in breast cancer
screening, healthy women with a high risk of developing breast cancer will
undergo Gd-DCE MRI scans annually from the age of thirty. Since doubts have
been raised about the side-effects of Gd-containing contrast agents it becomes
desirable to have an alternative to the administration of contrast agent.
Velocity Selective Arterial Spin Labeling (VS-ASL) is an MR-perfusion technique
that does not require administration of contrast agent. While other ASL methods
have problems obtaining enough signal in breast because of the complicated
vascular bed and slow flow, VS-ASL is more suitable, because it creates signal
closer to the target tissue. Feasibility and optimization of VS-ASL as breast
cancer screening-tool will need to be performed in patients with (early-stage)
breast cancer, since contrast in perfusion images will be too low to validate
and optimize this technique in healthy volunteers.

Primary Objective:
To study the feasibility of Velocity Selective Arterial Spin Labeling as a
non-invasive technique for breast cancer screening by comparing image quality
with DCE-MRI.

Secondary Objectives:
Comparing tumor characteristics and overall suspicion of cancer of VS-ASL and
DCE-MRI scans.
Comparing VS-ASL and DCE-MRI outcome to biopsy results (if available).

Other Objective:
To further optimize the VS-ASL technique by varying sequence parameters.

Single-center feasibility study

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

There are no known risks or adverse effects to MRI, beside occasional dizziness
and claustrophobia. VS-ASL is a standard MRI-scan technique, not needing any
contrast agent, and not posing any additional burden or risk to the patient.
Therefore, burden for subjects can be considered to be relatively low in this
study. Since the patients would undergo the MRI examination including DCE-MRI
irrespective of their participation in the study, it is not expected that the
additional VS-ASL scan will provide new diagnostic information and this scan
will not be used for clinical purposes.
The only concern is that the VS-ASL scan needs to be acquired prior to contrast
agent injection, whereas the contrast-enhanced scans are needed for clinical
purposes. To avoid the possibility that after the VSASL-scan the patient is not
able to finish the examination, we will ask the subject prior to the VSASL scan
whether she is willing to undergo the additional 7 min of scanning.