colorectal livermetastases
Conditions
Interventions
None listed
Sponsors
Philips Research
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Non-resectable colorectal liver metastases - Liver metastases of which a histological biopsy can safely be obtained: * Patients with safely accessible liver lesions according to an intervention-radiologist. * Patients not known with bleeding disorders (such as hemophilia) or bleeding complications from biopsies, dental procedures or surgery. * Patients not using any anti-coagulant medication at the time of biopsy: all aspirin derivatives, NSAID*s, coumarines, platelet function inhibitors, heparins (including LMWHs) and oral factor Xa inhibitors are not allowed, unless medication can either be safely stopped or counteracted. * Adequate hematology and coagulation status as measured by: * Hb > 6.0 mmol/L * Platelet count > 100 x 109/L * PT 18y
Exclusion criteria
Exclusion criteria: - Patients with suspected sensitivity to light; e.g. patients who have had photodynamic therapy -Patients who have higher risk of bleeding, such as patients with coagulopathy or patients who receive anticoagulants
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Objective: In this pilot study we aim to evaluate whether the results of the diffuse reflectance and fluorescence spectra can be used for response monitoring of first line systemic therapy in patients with colorectal liver metastasis. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Objectives: To compare the accuracy of response monitoring using spectroscopy with standardized RECIST criteria. To correlate spectroscopic measurements with tissue characteristics from biopsies. During the measurement procedure, possible improvements of the measurement hardware will be recorded which can provide information for possible alterations of hardware design for improved clinical applicability in the future. | — |
Countries
Netherlands
Outcome results
None listed