ltra high field 7.0 Tesla MR Spectroscopy to monitor capecitabine metabolism in liver metastases – a proof of concept study

Phase 1

• Conditions: Colorectal carcinoma; MedDRA version: 19.0Level: LLTClassification code 10010036Term: Colorectal carcinomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-000092-24-NL
• Lead Sponsor: niversity Medical Center Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-16
• Last Update Posted: 8 August 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

-18 years or older.
-Patients with liver metastases measurable according to RECIST in metastatic colorectal cancer.
-Patients that are planned to start with capecitabine (Xeloda®) and bevacizumab (Avastin®) treatment as determined according to Dutch guidelines.
-Informed consent for longitudinal data collection according to the PLCRC study protocol.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 26
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 26

Exclusion Criteria

- Patients that received any prior systemic therapy for cancer.
- Patients that received any prior radiotherapy or surgery in the liver.
- 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.
- Patients with claustrofobia.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified