The PLCRC substudy Ultra high field 7.0 Tesla MR Spectroscopy to monitor capecitabine metabolism in liver metastases - a proof of concept study
- Conditions
- bowel cancerColorectal cancer10017990
- Registration Number
- NL-OMON43450
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 26
-18 years or older.
-Patients with liver metastases measurable according to RECIST in metastatic colorectal cancer.
-Patients that are planned to start with capecitabine and bevacizumab treatment as determined according to Dutch guidelines.
-Informed consent for longitudinal data collection according to the PLCRC study protocol.
• Patients receiving triple chemotherapy for mCRC.
• Patients that received or currently receive any other kind of systemic therapy for cancer.
• Patients that received any prior radiotherapy or surgery in the liver.
• Patients with a dihydropyrimindine dehydrogenase (DPD) deficiency (heterozygous or homozygous).
• Contra-indications to MRI scanning according to hospitals 7T MRI screening guideline of the UMCU.
• Patients with severe liver dysfunction.
• Patients with a life expectancy of < 3 months.
• Pregnant or lactating women.
• Claustrofobia.
Exclusion criteria phase 2
• Patients that withdraw treatment with capecitabine and bevacizumab within the first three cycli.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>7T MRS characteristics on (changes in) concentration of capecitabine and<br /><br>metabolites measured in liver metastasis during MRS examinations obtained at<br /><br>discretized time point(s).</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints include response measurements (complete response, partial<br /><br>response, stable disease and progressive disease) according to RECIST and<br /><br>detailed information on perfusion, diffusion and acidity as determined by<br /><br>functional MRI.</p><br>