Saving breast cancer patients from ineffective treatment.
Recruiting
- Conditions
- breast cancer - borsht kankerneoadjuvant chemotherapy - neoadjuvante chemotherapieresponse to therapy - response op therapie31P Magnetic Resonance Spectroscopy - fosfor Magnetische resonantie spectroscopieMRI- MRI
- Registration Number
- NL-OMON28036
- Lead Sponsor
- niversity Medical Centre UtrechtAmsterdam Medical Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 126
Inclusion Criteria
•age of 18 years or older
•female breast cancer patients (HER2 negative breast cancer, stage II or III)
Exclusion Criteria
•any prior surgery or radiotherapy to the ipsilateral breast
•Karnofsky score <= 70,
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main study parameters are the signal ratios of ME/PDE or alternatively PME/Pi as obtained with 31P-MRS that should discriminate between responders and non-responders. Non responders show unchanged or even higher PME/PDE and PME/Pi ratios after the first cycle of chemotherapy whereas (partial) responders show a significant decrease in these ratios.
- Secondary Outcome Measures
Name Time Method Secondary study parameters as measured with (DCE-MRI, DWI, CEST-MRI) of the tumor prior to chemotherapy and after the first cycle of chemotherapy:<br>- DCE-MRI: Ktrans and kep values;<br>- DWI: ADC values;<br>- CEST-MRI: magnetisation transfer ratio (MTR) values