The purpose of the study is to determine the added value of multivoxel Magnetic Resonance Spectroscopy (MRS) in women with increased risk for breast cancer and equivocal enhanced breast lesions detected at screening with standard Dynamic Contrast…
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Mulitvoxel MRS can differentiate between benign and malignant breast lesions in
equivocal enhancing lesions on the DCE-MRI. Unnecessary biopsy can be prevented
in case of a benign lesion. When a woman has proven breast cancer and more
enhancing breast lesions are present in the same breast (or contralateral
breast) which are benign, unnecessary extended breast surgery can be prevented
with multivoxel MRS and thereby overtreatment.
Secondary outcome
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.
Background summary
Dynamic contrast enhanced breast MRI has the highest overall negative
predictive value (NPV) of all imaging techniques and is therefore able to
safely exclude malignancy (NPV > 98%). The problem with DCE-MRI is that
enhancement patterns show considerable overlap in malignant and benign breast
lesions. Therefore, the majority of the enhanced breast lesions are considered
equivocal. . A substantial amount of these women will undergo unnecessary
invasive procedures in case of an equivocal lesion.
Multivoxel MRS, performed according to the protocol of Sijens et al. (Sijens
2010), is a non-invasive technique that can provide tumor metabolic
information. The diagnostic value of MRS is generally based on the detection of
elevated levels of choline containing compounds. From the multivoxel MRS scan,
the mean and highest choline concentration within each equivocal enhancing
breast lesion is calculated. A threshold of 1.5 mM is used to differentiate
between benign and malignant breast lesions. In recent publications no overlap
of the highest choline concentration was found between benign and malignant
breast lesions. Breast lesions with the highest choline concentration <= 1.5mM
were benign and breast lesions with the highest choline concentration >= 1.7 mM
were malignant (Dorrius 2011).
Study objective
The purpose of the study is to determine the added value of multivoxel Magnetic
Resonance Spectroscopy (MRS) in women with increased risk for breast cancer and
equivocal enhanced breast lesions detected at screening with standard Dynamic
Contrast Enhanced Magnetic Resonance Imaging (DCE-MRI). The second aim is to
assess whether or not women prefer this new diagnostic modality.
Study design
In this prospective consecutive study 77 women with an enhancing breast lesion
classified as BIRADS >= 3 and a size of >= 0.8 cm on DCE-MRI will be included.MR
scans are performed at a 3.0T system using a whole body MR scanner with a
dedicated bilateral breast coil. Women will undergo the standard MRI protocol
(T2 weighted image and dynamic T1 weighted images with I.V. contrast medium and
diffusion weighted imaging (DWI)) for screening in prone position. In case an
enhanced breast lesion is assessed as BIRADS >=3 and the lesion is >= 0.8 cm, the
woman will return to the hospital for the standard work-up (target ultrasound
and if visible on ultrasound followed by ultrasound guided biopsy). Prior to
the standard work-up a multivoxel MRS will be made. This is a MRI sequence
without I.V. contrast and has a duration of approximately 20 minutes (protocol
of Sijens et al 2010). Histopathology or 6 months follow-up DCE-MRI is set as
the regular follow-up in this study. A questionnaire will be used to assess
whether women prefer the new diagnostic modality or biopsy.
Study burden and risks
Until now, no hazardous effects of the MRI are documented. The burden for the
patient is an extra MRI scan of 20 minutes and filling out a questionairre.
However these patients are familiar with a MRI scan, because they undergo a
screenings MRI scan every year.
Hanzeplein 1
Groningen 9700 RB
NL
Hanzeplein 1
Groningen 9700 RB
NL
Listed location countries
Age
Inclusion criteria
Seventy-seven women with a solid breast lesion >= 0.8cm and BIRADS classification >= 3 on the MRI will be consecutively enrolled into the study
Inclusion 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 >= 25% or prior radiation therapy to the chest below age 40.
Exclusion criteria
breast hematoma or bilateral breast implants.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL58550.042.16 |
| Other | volgt |