|- candidate number||10285|
|- NTR Number||NTR3048|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||29-aug-2011|
|- Secondary IDs||NL 36419.041.11 CCMO|
|- Public Title||"Contrast-enhanced MR imaging of the breast at 7T and 3T in the same patients".|
|- Scientific Title||"Contrast-enhanced MR imaging of the breast at 7T and 3T in the same patients".|
|- ACRONYM||7T vs. 3T beast MRI study|
|- hypothesis||This is a prospective cross-sectional study aimed at assessing the diagnostic performance of 7T CE breast MRI compared to the clinical standard of 3T MRI and histopathology, on a intra-individual basis. |
|- Healt Condition(s) or Problem(s) studied||Breast cancer|
|- Inclusion criteria||1. 18 years or older;|
2. Female patients;
3. A BI-RADS 4 or higher classification for a lesion detected on mammography and/or ultrasound.
|- 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 < 30mL/min/1.73m2.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-nov-2011|
|- planned closingdate||1-sep-2012|
|- Target number of participants||60|
|- Interventions||Two contrast-enhanced breast MRI scans; 7 Tesla MRI & 3 Tesla MRI.|
|- Primary outcome||The primary aim is to assess the diagnostic performance of 7T CE breast MRI. This is done by comparing the final 7T BI-RADS-MRI classification to the final 3T BI-RADS-MRI classification and to histopathology obtained after biopsy and surgery. |
|- Secondary outcome||1. To establish the per-lesion diagnostic accuracy of 7T;|
2. Comparison of lesion size as determined at 7T, 3T and final pathology.
|- Timepoints||Patients with a BI-RADS 4 of higher classification will be submitted to two MRI exams.|
The endpoint of follow-up for all included patients will be final histological evaluation.
|- Trial web site||N/A|
|- 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 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, 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 is required as well as of the presence or absence of lesions in other quadrants of the breast.
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. 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 means not just detection of smaller lesions, but also better morphologic classification of detected lesions and better delineation of lesion extent.
The preliminary results of our nearly finished technical feasibility study of CE breast MRI at 7T (NL32664.041.10) has concluded that contrast-enhanced 7T breast MRI is technically feasible and reasonably well tolerated. Both morphology as well as kinetic assessments could be conducted, in accordance with the BI-RADS-MRI criteria. The next step is to assess the diagnostic performance of 7T CE-MRI in comparison with the current diagnostic standard of 3T MRI and histopathology.
|- Main changes (audit trail)|
|- RECORD||29-aug-2011 - 12-sep-2011|