Clinical trial · Observational
PET-MRI After Radiofrequency Ablation (RFA) or Microwave Ablation (MWA)
The Use of PET-MRI in the Follow-up of RFA and MWA Treated Colorectal Liver Metastases
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary objective of this study is to evaluate the ability of PET-MRI and to detect a local site recurrence during the first year of follow-up after RFA or MWA of colorectal liver metastases (CRLM) as compared with contrast enhanced (ce) CT and PET-CT. Standard reference will be clear focal uptake in the rim of the lesion on PET-CT, possibly in combination with histology (when available) or clinical follow-up. Secondary outcomes are the inter-observer variability, the ability to diagnose new intrahepatic lesions and in what way PET-MRI is able to influence future treatment compared to PET-CT and ceCT. The patients satisfaction concerning the PET-MRI will be examined with a questionnaire.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Neoplasms | Liver Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Local Neoplasm Recurrence | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gadolinium | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- PET-MRI
- description
- Twenty patients with RFA/MWA for CRLM or RFA/MWA of recurrent liver lesions after prior local treatment of CRLM and are eligible to undergo MRI-scanning are included when they have adequate renal function. Patients that do not meet inclusion criteria for undergoing an MRI scan are excluded.
- interventionNames
- Other: Gadolinium
Primary outcomes (1)
- measure
- Local site recurrence (LSR) detection
- timeFrame
- 1 year
- description
- The primary objective of this study is to evaluate the ability of PET-MRI and diffusion and contrast enhanced MRI to detect LSR during the first year of follow-up after RFA treatment of CRLM as compared with ceCT and PET-CT. Standard reference will be clear focal uptake in the rim of the lesion on PET-CT, possibly in combination with histology (when available) or clinical follow-up.
Secondary outcomes (4)
- measure
- Detection new intrahepatic lesions
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histological or cytological documentation of primary colorectal tumor * Radiological or histological prove of one or more CRLM or radiological proof 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 Free University (VU) University Medical Center * Age ³ 18 years * Life expectancy of at least 1 year * estimated glomerular filtration rate (eGFR) \> 60 or hydration according to protocol before scanning * Written informed consent. Exclusion Criteria: * cirrhosis or steatosis of the liver * 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 1. claustrophobia 2. intracranial clips 3. any implanted stimulation device (eg. internal cardioverter defibrillator/pacemaker, cochlear implant) 4. intra-ocular metal splinters or metal clips 5. Metal artificial heart valve 6. Bone prosthesis \< 6 weeks 7. inability to lie still for 30 minutes 8. orthopnea 9. intestinal video capsule 10. Metal intra auricular prosthesis all other prosthesis or piercings should be removed.
References
Publications (1)
- DERIVEDNielsen K, Scheffer HJ, Pieters IC, van Tilborg AA, van Waesberghe JH, Oprea-Lager DE, Meijerink MR, Kazemier G, Hoekstra OS, Schreurs HW, Sietses C, Meijer S, Comans EF, van den Tol PM. The use of PET-MRI in the follow-up after radiofrequency- and microwave ablation of colorectal liver metastases. BMC Med Imaging. 2014 Aug 8;14:27. doi: 10.1186/1471-2342-14-27. PMID 25103913