Feasibility of 7T beast MRI for the detection of breast cancer.
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the 7T detection rate of stage T1 breast cancer
lesions.
Secondary outcome
- To assess the morphology of the cancer lesions as described in the MRI
BI-RADS
lexicon.
- To assess the kinetics of lesion enhancement.
- To assess the correlation of 7T MRI analysed lesions sizes to the sizes as
determined in
the final pathological analysis.
Background summary
Every year over 10.000 Dutch women are diagnosed with invasive breast cancer.
This makes breast cancer the cancer type with the highest incidence in Dutch
women.
When a breast lesion is detected, conventional triple diagnosis, which consists
of palpation, mammography and fine-needle cytology, currently with the addition
of ultrasound imaging, is performed to establish the diagnosis. Before
treatment can be initiated accurate staging needs to be conducted to develop an
individualized treatment plan. Staging requires precise knowledge of the size
of the index lesion as well as of the presence or absence of lesions in other
quadrants of the breast.
Magnetic resonance imaging has an additional value in the staging of breast
cancer due to its capability to depict multicentric and multifocal disease, to
assess the tumor in a three-dimensional way and to detect lesions in dense
breast tissue. In recent years there has been an increasing interest in MRI as
a non-invasive diagnostic modality for the work-up of suspicious breast
lesions. The sensitivity of MRI for diagnosing breast cancer is over 90% with
specificity around 70%
Recently ultra-high field 7.0 Tesla MRI has become clinically available. The
availability of ultra high field 7T MRI offers new diagnostic possibilities:
due to the very high magnetic field strength of the scanner, images can be
acquired at a higher spatial resolution allowing smaller structural detail to
be depicted. For breast cancer this would mean not just the detection of
smaller lesions, but also better morphologic classification of detected lesions
and better delineation of lesion extent.
Study objective
Feasibility of 7T beast MRI for the detection of breast cancer.
Study design
Prospective cohort study.
Study burden and risks
The patient will have to fill out an MRI safety form before entering the 7T MRI
area. An iv catheter will be inserted to administer contrast agent used during
the MRI exam. The patient will undergo one MRI exam.
As far as is known there are no short- or long term risks involved in having an
MRI examination. Some patient will experience light flashes or tingling due to
the very high magnetic field of the 7 Tesla MRI. This will immediately
disappear as soon as leaving the scanning area. Participants are not requested
to take any precautions or actions following to or prior to the MRI exam.
The contrast agent administered during the exam is daily used in clinical
practice during imaging. In rare cases an allergic reaction can occur, such as
an itch, nausea or small bumps on the skin. In the vast majority of cases these
symptoms pass quickly. In extremely rare cases acute allergic reactions can
occur, in patients with known contrast allergies, which do require medical
treatment. Therefore these patients are excluded from participation in this
study. For safety reasons at all times a patient is scanned on the 7T MRI and
contrast is given a medical doctor will be present.
Heidelberglaan 100
Postbus 85500 3508 GA Utrecht
NL
Heidelberglaan 100
Postbus 85500 3508 GA Utrecht
NL
Listed location countries
Age
Inclusion criteria
- 18 years or older
- Female patients
- A breast lesion <2cm with BIRADS 4c or higher classification on mammography, US and/or
lower field MRI
- Lesion with maximum dimension of 2 cm
Exclusion criteria
- Any prior surgery or radiotherapy to the ipsilateral breast
- Karnofsky score <= 70
- Pregnant or lactating women
- Contra-indications to MRI scanning according to the 7T screening list of the UMCU
- Contra-indications to injection of gadolinium-based contrast-agent, including known
prior allergic reaction to any contrast-agent, and renal failure, defined by GFR <
30mL/min/1.73m2.
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 | NL32664.041.10 |
OMON | NL-OMON20303 |