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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.
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:
The reports on new intrahepatic lesions will be scored as follows:
The results of all scans by the reviewers, in the way as described above, will be compared to each other to determine the inter-observer variability using Cohen's Kappa.
A questionnaire with 7 questions is completed at the end of one year follow-up to determine patients experience with PET-MRI and PET-CT.
The questions will be in Dutch, but are translated below for this purpose. Patients can answer on a scale 1-5 and n/a.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PET-MRI | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gadolinium | Other | All patients will undergo PET-MRI additional to the PET-CT they routinely undergo. All patients will be administered Gadolinium for the PET-MRI scan. This is an extra intervention than they would normally undergo. |
| Measure | Description | Time Frame |
|---|---|---|
| Local site recurrence (LSR) detection | 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. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Detection new intrahepatic lesions | the ability of PET-MRI to diagnose smaller new intrahepatic lesions than PET-CT and ceCT | 1 year |
| inter-observer variability | Hard copy data sets of all PET-MRI and PET-CT scans, with no patient information, random order, independently reviewed by 2 experienced radiologists and 2 nuclear medicine physicians twice (reviewers blinded to the images and results of the other imaging modalities and blinded to the final outcome of patients), with a time-interval of at least two weeks between the first and second review. These scans are scored on a standardized form (explained in the section 'detailed description'). The outcomes between the different reviewers of the same scan are noted and compared to each other. Inter observer variability is determined using Cohen's Kappa. |
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Inclusion Criteria:
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
all other prosthesis or piercings should be removed.
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Twenty patients with primary CRLM or recurrent liver disease after prior local treatment of CRLM that have been treated with RFA or MWA 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.
Patients are recruted by the study coordinators (K Nielsen or HJ Scheffer) when meeting in- and exclusion criteria from the VU Univeristy medical centre and the Gelderse Vallei hospital in Ede. All scans will be made in the VU University medical centre.
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| Name | Affiliation | Role |
|---|---|---|
| Petrousja van den Tol, MD PhD | VU University Medical Centre | Principal Investigator |
| Indra C Pieters, MD PhD | VU University Medical Centre | Principal Investigator |
| Emile FI Comans, MD PhD | VU University Medical Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VU University Medical Centre | Amsterdam | North Holland | 1081 hv | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25103913 | Derived | Nielsen 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. |
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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| D009364 | Neoplasm Recurrence, Local |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D005682 | Gadolinium |
| ID | Term |
|---|---|
| D028581 | Lanthanoid Series Elements |
| D008674 | Metals, Rare Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
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| 1 year |
| Influence on decision making | in what way PET-MRI is able to change future treatment compared to PET-CT and ceCT | 1 year |
| Patients experience with PET-CT and PET-MRI | A questionnaire with 7 questions is completed at the end of one year follow-up to determine patients experience with PET-MRI and PET-CT. This is done to get an idea of the possible objections and wishes of all patients. Results will be described. The questions will be in Dutch, but are translated below for this purpose. Patients can answer on a scale 1-5 and n/a.
| end of one year follow-up |
| D008107 |
| Liver Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008670 |
| Metals |