|- candidate number||8271|
|- NTR Number||NTR2435|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||29-jul-2010|
|- Secondary IDs||NL32664.041.10 CCMO|
|- Public Title||Feasibility of ultra high field 7.0 Tesla MRI
for the detection of breast cancer.|
|- Scientific Title||Feasibility of ultra high field 7.0 Tesla MRI
for the detection of breast cancer.|
|- ACRONYM||7T breast MRI study|
|- hypothesis||This is a single centre prospective cohort study aimed at the technical feasibility of 7T contrast enhanced breast MRI.
|- Healt Condition(s) or Problem(s) studied||Breast cancer, Neoplasia|
|- Inclusion criteria||1. 18 years or older;|
2. Female patients;
3. A BI-RADS 4c or higher lesion ≤ 2 cm on mammography, ultrasound and/or lower field strength MRI.
|- Exclusion criteria||1. Any prior surgery or radiotherapy to the ipsilateral breast;|
2. Karnofsky score <= 70;
3. Pregnant or lactating women;
4. Contra-indications to MRI scanning according to hospitals 7T MRI screening guidelines;
5. Contra-indications to injection of gadolinium-based contrast agent, including known prior allergic reaction to any contrast-agent, and renal failure, defined by GFR <
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-sep-2010|
|- planned closingdate||1-apr-2011|
|- Target number of participants||20|
|- Primary outcome||The primary endpoint is the 7T detection rate of stage T1 breast cancer lesions in a cohort of women with BI-RADS 4c of higher lesion at mammography, ultrasound and/or lower field strength MRI. |
|- Secondary outcome||1. To assess the morphology of breast cancer at 7T as described according to the MRI BI-RADS lexicon;|
2. To assess the kinetics of lesion enhancement at 7T;
3. To assess the correlation of 7T MRI lesion size and lesion size as determined by final pathological analysis.
|- Timepoints||Patients with a BI-RADS 4c or higher classification will be submitted to one contrast enhaced 7T MRI exam before a biopsy will be performed. |
The endpoint of follow-up for all included patients is the final histological evaluation, which in most patients will be after surgery; mastectomy or lumpectomy.
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||MD. B.L. Stehouwer|
|- CONTACT for SCIENTIFIC QUERIES||MD. B.L. Stehouwer|
|- Sponsor/Initiator ||University Medical Center Utrecht (UMCU)|
(Source(s) of Monetary or Material Support)
|- Brief summary||Every year more than 10.000 Dutch women are diagnosed with breast cancer. This makes breast cancer the cancer with the highest incidence in Dutch women.
When a breast lesion is detected conventional triple diagnosis - 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.
Magnetic resonance imaging has 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. |
Recently ultra-high field 7.0 Tesla MRI has become clinically available. 7T breast MRI offers new diagnostic abilities that have the potential to improve the staging of breast cancer patients.
Before 7T MRI can be implemented in clinical practice, validation is needed.
This is a prospective cohort study aimed at validating the 7T detection rate of breast cancer. The validation will be based on a detailed 7T MRI compared to histological correlation, where histology will be regarded the golden standard.
|- Main changes (audit trail)|
|- RECORD||29-jul-2010 - 23-jun-2012|