An observational study in Liver Neoplasms and Local Neoplasm Recurrence, sponsored by dr. M.P. van den Tol MD PhD. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-12-15.
Sponsored by dr. M.P. van den Tol MD PhD · Observational
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.
9,359 studies on the registry are indexed under Neoplasms; 2,486 are open to participants now.
This study's enrollment of 20 is below the median of 205 across 1,680 observational studies indexed under Neoplasms.
Browse Neoplasms studies →This is the only study on the registry with dr. M.P. van den Tol MD PhD as lead sponsor.
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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.
Exclusion Criteria:
General exclusion criteria to undergo MRI
all other prosthesis or piercings should be removed.
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.
Other: Gadolinium
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.
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.
Time frame: 1 year
Detection new intrahepatic lesions
the ability of PET-MRI to diagnose smaller new intrahepatic lesions than PET-CT and ceCT
Time frame: 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.
Time frame: 1 year
Influence on decision making
in what way PET-MRI is able to change future treatment compared to PET-CT and ceCT
Time frame: 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. * The PET-MRI was less burdensome than PET-CT * The PET-MRI was more bothersome than I expected * PET-MRI is more comfortable than PET-CT * If I could choose, I would rather undergo PET-MRI than PET-CT * The noise of the PET-MRI was annoying * The fact that PET-MRI takes longer than PET-CT isn't an issue for me * I would rather undergo a PET-MRI than a PET-CT if results are proven to be equal
Time frame: end of one year follow-up
This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
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