1. to investigate the prognostic relevance of [18F]FLT uptake in resectable liver metastases of patients with colorectal cancer, in addition to existing prognostic indices with respect to disease-free survival; 2. in chemonaive patients, to validate…
ID
Source
Brief title
Condition
- Hepatobiliary neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
prognostic accuracy of [18F]FLT uptake in liver metastases with respect to
patient outcomes (DFS),
Secondary outcome
prognostic accuracy of [18F]FLT uptake vs. existing prognostic indices with
respect to patient outcomes (DFS).
Background summary
One-third of colorectal cancer patients have liver metastases at presentation,
and 25% develop them after primary surgery. Patient management is dictated by
technical resectability, residual liver function and absence of extrahepatic
metastases. A Dutch multicentre ZON-MW study showed that preoperative [18F]FDG
PET (by showing additional dissemination) reduces futile surgery by 38%. Still
after surgery, outcome is highly variable (5 yrs survival 30-50%), and
prognostic indicators beyond TNM staging are clearly needed.
With new systemic therapies emerging, biomarkers are needed to adapt
(multimodality) therapy to the biological tumour profile of individual
patients. Proliferation markers are variably successful, perhaps due to
heterogeneity (spatial [within tumours] and/or temporal [differences between
primary vs. metastatic]). Conceptually, the S-phase fraction related
Fluorine-18 3-deoxy-3-fluorothymidine ([18F]FLT) PET signal preoperatively adds
these spatial and quantitative dimensions.
Study objective
1. to investigate the prognostic relevance of [18F]FLT uptake in resectable
liver metastases of patients with colorectal cancer, in addition to existing
prognostic indices with respect to disease-free survival;
2. in chemonaive patients, to validate the association between standard
histopathological proliferation markers in liver metastases and [18F]FLT
uptake.
Study design
observational multicentre cohort study
Intervention
[18F]FLT PET(-CT).
Study burden and risks
benefit and group relatedness: single [18F]FLT PET- CT scan, yielding 4.4 mSv
for a typical PET-CT acquisition. During the study, [18F]FLT PET studies will
not be used for patient management.
De Boelelaan 1117
1081 HV Amsterdam
NL
De Boelelaan 1117
1081 HV Amsterdam
NL
Listed location countries
Age
Inclusion criteria
*technically resectable liver metastases at the time of hepatic recurrence diagnosis
*written informed consent
Exclusion criteria
*claustrophobia prohibiting PET-scanning
*systemic cancer therapy within 3 months prior to PET
*largest liver metastasis <2 cm
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 |
|---|---|
| EudraCT | EUCTR2009-017150-12-NL |
| CCMO | NL29807.029.10 |