Pilot study: The use of PET-MRI in the follow-up of RFA treated colorectal liver metastases

Phase 2

Completed

Conditions: Local site recurrence after radiofrequency ablation of colorectal liver metastases
synonyme: treatment failure of radiofrequency ablation of metastases in the liver derived from colorectal carcinoma
10019815
10027476
10019818

Registration Number: NL-OMON38868

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

Histological or cytological documentation of primary colorectal tumor
Radiological or histological prove of one or more CRLM or radiological prove of a LSR after previous RFA/MWA treatment for CRLM
CRLM or LSR treated with RFA/MWA or RFA/MWA in combination with resection
Follow-up imaging performed in VUmc medical centre
Age ³ 18 years
Life expectancy of at least 1 year
eGFR > 60 or hydration according to protocol before scanning

Exclusion Criteria

Cirrosis or steatosis
Chemotherapy * 6 weeks before scanning (during the entire study)
Pregnant or breast-feeding subjects
Allergy to contrast media
Patients developing recurrent intrahepatic disease that require resection of the ablated lesion
eGFR < 60, unless hydration according to protocol is possible
General exclusion criteria to undergo MRI

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome is the ability of PET-MRI in the detection of LSR in the liver<br /><br>compared to ceCT of the liver and PET-CT referred to histological findings or<br /><br>clinical follow-up. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes are the inter-observer variability, the ability to diagnose<br /><br>new intrahepatic lesions and in what way PET-MRI is able to influence future<br /><br>treatment compared to PET-CT and ceCT. The patients satisfaction concerning the<br /><br>PET-MRI will be examined with a questionnaire. </p><br>