The primary objective of this study is to evaluate the ability of PET-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 histology (when available) or…
ID
Source
Brief title
Condition
- Hepatobiliary neoplasms malignant and unspecified
- Metastases
- Hepatobiliary therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome is the ability of PET-MRI in the detection of LSR in the liver
compared to ceCT of the liver and PET-CT referred to histological findings or
clinical follow-up.
Secondary outcome
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.
Background summary
The main area of concern regarding radiofrequency ablation (RFA) or microwave
ablation (MWA) of colorectal liver metastases (CRLM) is the risk of developing
a local site recurrence (LSR). Imaging plays a key role in diagnosing LSR after
RFA or MWA liver treatment. When LSR is diagnosed adequately and timely,
optimal effect of repeated (minimal invasive) local treatment may be obtained.
So far a contrast enhanced (ce) CT scan is generally used for follow-up,
However, post-treatment effects in the ablation margin may complicate an
adequate diagnosis of LSR for which the addition of FDG-PET helps to
differentiate between metabolic active tumor tissue and inactive post-ablation
mass. Therefore an integrated FDG PET-CT is favourable over CT alone and the
combination of both is standard of care in our centre. Liver MRI with contrast
outperforms CT in the detection of small hepatic metastases (<1 cm), but its
role is not yet established for the follow-up after RFA or MWA. Therefore, the
combination of FDG PET to determine metabolic activity with the ability of the
MRI to detect small lesions may add to timely and correctly diagnosing a LSR.
This may lead to earlier initiation of effective treatment. With the recent
launch of PET-MRI, these two advantages can be combined.
Study objective
The primary objective of this study is to evaluate the ability of PET-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 histology (when
available) or clinical follow-up.
Study design
Multi centre pilot study
Study burden and risks
All participating patients will receive follow-up according to normal standards
in our hospital (ceCT of the liver and a PET-CT 3-4 monthly in the first year).
These imaging modalities are currently leading in the evaluation of local
response to RFA and MWA treatment and to diagnose new intra- and extrahepatic
metastatic disease. Therefore in this study, the decision on treatment will not
be made based on the results of the PET-MRI, but based on PET-CT and ceCT,
sometimes in combination with CEA at the surgeons or oncologists discretion.
The PET-MRI images will be evaluated separately and results will be compared to
PET-CT and ceCT. The additional risks for participating patients with normal
renal function, when normal in- and exclusion criteria for MRI research are
being followed are limited. There is no increased exposure to radiation and the
patients only need a single dose of FDG for both PET-CT and PET-MRI. The risk
on nefrogenic systemic fibrosis after use of gadolinium is negligible in
patients with adequate renal function. Undergoing a PET-MRI of the liver will
cost the participant extra time; 45 minutes extra for scanning protocol. We
will put much effort in reducing the waiting time in between scans as much as
possible. Travel time may be longer for than usual for patients from the
Gelderse Vallei.
Boelelaan 1117
Amsterdam 1081 HV
NL
Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
Histological or cytological documentation of primary colorectal tumor
Radiological or histological prove of one or more CRLM or radiological prove 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 VUmc medical centre
Age ³ 18 years
Life expectancy of at least 1 year
eGFR > 60 or hydration according to protocol before scanning
Exclusion criteria
Cirrosis or steatosis
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
ClinicalTrials.gov | NCT01895673 |
CCMO | NL43058.029.13 |