The Use of PET-MRI in the Follow-up of RFA and MWA Treated Colorectal Liver Metastases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Local site recurrence (LSR) detection
研究概览
简要总结
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.
详细描述
All included patients will routinely undergo follow-up with 3 monthly ceCT of the liver and PET-CT in the first year after RFA/MWA of CRLM according to standard of care in our hospital. Patients are asked to undergo an additional PET-MRI of the liver on the same day in the first year (in total 4 scans). The PET-MRI is obtained before the PET-CT. The 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (FDG) used for PET-CT and PET-MRI are alike and one injection is sufficient. The PET-CT has to be made within 150 minutes after FDG injection. Anonymous PET-MRI results are independently reviewed by 2 experienced radiologists and 2 nuclear medicine physicians twice, with a time-interval of at least two weeks between the first and second review. Based on these results, treatment decisions will be compared for any change in decision making.
The evaluate inter-observer variability we will ask the two nuclear medicine physicians and two radiologist to assess all results and score local and intrahepatic tumor progression. Results of the first and second evaluation will be compared to determine inter observer agreement using Cohen's Kappa. Local recurrence and new lesions will be scored on a separate form with standard criteria.
The reports on LSR will be scored as follows:
- Normal: when the reviewer is sure that no tumor recurrence is present in the ablation zone.
- Probably benign: FDG is enhanced, but compatible with post-ablation inflammation or rim-like characteristics on MRI images (not focal!)
- Equivocal: there is doubt whether the enhanced FDG, CT- or MRI features are due to tumor recurrence or inflammation
- Probably malign: when the reviewer is sure about local recurrence in the ablation zone. Size and location will also be reported.
The reports on new intrahepatic lesions will be scored as follows:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
- •claustrophobia
- •intracranial clips
- •any implanted stimulation device (eg. internal cardioverter defibrillator/pacemaker, cochlear implant)
- •intra-ocular metal splinters or metal clips
- •Metal artificial heart valve
- •Bone prosthesis < 6 weeks
- •inability to lie still for 30 minutes
- •intestinal video capsule
- •Metal intra auricular prosthesis
- •all other prosthesis or piercings should be removed.
结局指标
主要结局
Local site recurrence (LSR) detection
时间窗: 1 year
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.
次要结局
- inter-observer variability(1 year)
- Influence on decision making(1 year)
- Detection new intrahepatic lesions(1 year)
- Patients experience with PET-CT and PET-MRI(end of one year follow-up)
研究者
dr. M.P. van den Tol MD PhD
PhD
Amsterdam UMC, location VUmc