Liver NeoplasmsNCT01895673
PET-MRI After Radiofrequency Ablation (RFA) or Microwave Ablation (MWA)
An observational study of Liver Neoplasms and Local Neoplasm Recurrence, run by dr. M.P. van den Tol MD PhD at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Neoplasms, Local Neoplasm Recurrence
- What is being tested?
- Gadolinium
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2013to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 18Show fewer
- 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
- orthopnea
- intestinal video capsule
- Metal intra auricular prosthesis
- all other prosthesis or piercings should be removed.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
VU University Medical Centre
Amsterdam, North Holland, 1081 hv
About this study
Official title: The Use of PET-MRI in the Follow-up of RFA and MWA Treated Colorectal Liver Metastases
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.
Read the detailed description
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:
- Normal: no new intrahepatic disease outside 1cm of the ablation zone
- Equivocal: doubt about the malignant origin of a lesion
- Probably malign: new intrahepatic tumor not within 1cm of the ablation zone, including size and location.
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.
- 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
- Conditions
- Liver Neoplasms, Local Neoplasm Recurrence
- Being tested
- Gadolinium
- Keywords
- FDG-PET, Radiofrequency Ablation, Magnetic Resonance Imaging
- Medical subject headings
- Liver Neoplasms, Neoplasm Recurrence, Local
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GadoliniumOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Gadolinium |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (4)
Detection new intrahepatic lesions
the ability of PET-MRI to diagnose smaller new intrahepatic lesions than PET-CT and ceCT
Measured: 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.
Measured: 1 year
Influence on decision making
in what way PET-MRI is able to change future treatment compared to PET-CT and ceCT
Measured: 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
Measured: end of one year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- dr. M.P. van den Tol MD PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, dr. M.P. van den Tol MD PhD, Amsterdam UMC, location VUmc
- Investigators
- Petrousja van den Tol, MD PhD, Principal investigator, VU University Medical CentreIndra C Pieters, MD PhD, Principal investigator, VU University Medical CentreEmile FI Comans, MD PhD, Principal investigator, VU University Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01895673
- Sponsor's protocol ID
- NL43058.000.13
- Status last verified
- Dec 2016
- First submitted
- 20 Jun 2013
- Last updated
- 15 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25103913
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of PET-MRI in the Follow-up of RFA and MWA Treated Colorectal Liver Metastases
- ClinicalTrials.gov ID
- NCT01895673
- Acronym / sponsor ID
- NL43058.000.13
- Conditions
- Liver Neoplasms, Local Neoplasm Recurrence
- Keywords
- FDG-PET, Radiofrequency Ablation, Magnetic Resonance Imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- dr. M.P. van den Tol MD PhDUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 10 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Normal: no new intrahepatic disease outside 1cm of the ablation zone
- Equivocal: doubt about the malignant origin of a lesion
- Probably malign: new intrahepatic tumor not within 1cm of the ablation zone, including size and location.
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.
- 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET-MRI | – | Other: GadoliniumTwenty 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GadoliniumAll 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. | Other | PET-MRI |
Primary outcome
Local site recurrence (LSR) detection
Time frame: 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.
4 secondary outcomes
Detection new intrahepatic lesions
Time frame: 1 year
inter-observer variability
Time frame: 1 year
Influence on decision making
Time frame: 1 year
Patients experience with PET-CT and PET-MRI
Time frame: end of one year follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2016.
- Derived from this study: PubMed 25103913Nielsen 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Petrousja van den Tol, MD PhD principal investigator
VU University Medical Centre
Indra C Pieters, MD PhD principal investigator
VU University Medical Centre
Emile FI Comans, MD PhD principal investigator
VU University Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Neoplasms and Local Neoplasm Recurrence, run by dr. M.P. van den Tol MD PhD at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local site recurrence (LSR) detection (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01895673, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2016.