The added value of multivoxel MR spectroscopy in young women with a high risk for breast cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON25637

Enrollment

Registered

2016-09-30

Start date

2016-11-01

Completion date

Unknown

Last updated

2024-06-11

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

Conditions

breast cancer

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: participation in a screening programme for a BRCA1 or BRCA2 gene mutation carrier, or other genetic predisposing with a markedly increased risk of breast cancer, such as untested first degree relativea of a gene mutation carrier, family history consistent with hereditary breast cancer, estimated personal lifetime breast cancer risk ¡Ý 25% or prior radiation therapy to the chest below age 40

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: breast hematoma or bilateral breast implants.

Design outcomes

Primary

Measure	Time frame
To determine the added value of multivoxel MRS in equivocal breast lesions detected through screening with DCE-MRI. This study will especially focus on young women with a high risk of breast cancer. The hypothesis is that with the application of a DCE-MRI scan with quantitative multivoxel MRS, 23% of the number of false positive breast lesions and related to that, the number of unnecessary invasive procedures, will be prevented as compared to a regular DCE-MRI.	—

Measure

Time frame

To determine the added value of multivoxel MRS in equivocal breast lesions detected through screening with DCE-MRI. This study will especially focus on young women with a high risk of breast cancer. The hypothesis is that with the application of a DCE-MRI scan with quantitative multivoxel MRS, 23% of the number of false positive breast lesions and related to that, the number of unnecessary invasive procedures, will be prevented as compared to a regular DCE-MRI.

—

Secondary

Measure	Time frame
The expectation is that women prefer the new non-invasive diagnostic work-up instead of the biopsy, and that this, when implemented in clinical practice will improve the quality of life of the women involved.	—

Contacts

Public ContactM.D. Dorrius

UMCG Dept. Of Radiology

m.d.dorrius@umcg.nl

Outcome results