Validation of 7T breast MRS for monitoring of neo-adjuvant chemotherapy in patients with breast cancer.
ID
Source
Brief title
Condition
- Breast neoplasms benign (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Sensitivity of 7T MRS detection of histological proven breast cancer. The in
vivo 7T MRS data will be compared to ex vivo measurements with HR-MAS and LC-MS.
2. Sensitivity of 7T MRS to monitor neo-adjuvant chemotherapy effects in
membrane metabolism
Secondary outcome
-
Background summary
Every year over 12.000 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 means not just the possibility of detection
of smaller lesions, but possibly also better morphologic classification of
detected lesions and better delineation of lesion extent. In addition, 7 Tesla
MRS offers the possibility to monitor therapy of lesions by means of the
detection of phospholipid metabolites that have shown clinical potential as
biomarkers for oncological disease in preclinical studies.
Study objective
Validation of 7T breast MRS for monitoring of neo-adjuvant chemotherapy in
patients with breast cancer.
Study design
prospective cohort study
Study burden and risks
The patient/volunteer will have to fill out an MRI examination form before
entering the 7T MRI area. The patient /volunteer will undergo 1 (group 2 and 3)
or 3 MRI / MRS exams.
As far as is known there are no short- or long term risks involved in having an
MRS 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 MRS exam.
Heidelberglaan 100
3584 CX Utrecht
Nederland
Heidelberglaan 100
3584 CX Utrecht
Nederland
Listed location countries
Age
Inclusion criteria
- 18 years or older
- Females
- Group 1: patients selected for neo-adjuvant chemotherapy
- Group 2: patients with BIRADS 4c or 5 classification on mammography, US or lower field MRI, selected for surgery
- Group 3: healthy volunteers
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL35649.041.11 |