An interventional study of Computed tomography X-ray system in Metastatic Colorectal Cancer, sponsored by Patrick Veit-Haibach. Terminated at 5 sites in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-12-16.
Sponsored by Patrick Veit-Haibach · Not applicable, Interventional, and Diagnostic
The primary objective of this study is to investigate the anti-angiogenic effect of bevacizumab measured by CTP as a predictive marker for efficacy measured by progression-free survival (PFS) in mCRC patients under first-line bevacizumab-containing, fluoropyrimidine-based chemotherapy
So far, CTP has provided non-invasive imaging of tumor biological response to anti-angiogenic and vascular targeting agents in a number of clinical trials with increasing clinical application. CTP can be examined with a variety of commercially available CE-certified CT scanners and imaging post-processing is possible with commercially available CE-certified software from different vendors, too. In several studies, anti-angiogenic effects have been detected with CTP but further evidence for its clinical validation has to be proven in clinical trials.
Changes in tumor vasculature measured by CTP will be correlated to the clinical efficacy parameters progression-free survival, overall survival and response rate, thus identifying a group of patients who profit most from the anti-angiogenic treatment.
5,738 studies on the registry are indexed under Colorectal Neoplasms; 1,483 are open to participants now.
This study's planned enrollment of 50 is below the median of 77 across 4,226 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →This is the only study on the registry with Patrick Veit-Haibach as lead sponsor.
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Confirmation of metastatic liver disease within one month prior to inclusion in one of the following radiological procedures:
Exclusion Criteria:
Patients undergo a total of four perfusion-computed tomographies from baseline to progression of disease.
Device: Computed tomography X-ray system
Contrast-enhanced computed tomography of liver metastases
Also known as: CT scanner
CTP as predictive marker for efficacy measured by progression-free survival
Predictive power of decrease in tumor vasculature on the clinical outcome in bevacizumab-based chemotherapy measured by progression-free survival (PFS). Decrease in tumor vasculature is measured by blood flow in CTP 3 compared to CTP 1 (baseline)
Time frame: one year
CTP as predictive marker for efficacy measured by progression-free survival
Predictive power of decrease in tumor vasculature on the clinical outcome in bevacizumab-based chemotherapy measured by progression-free survival (PFS). Decrease in tumor vasculature is measured by blood flow, blood volume, mean transit time and permeability surface-area product in CTP
Time frame: one year
CTP as predictive marker for efficacy measured by overall survival
Predictive power of decrease in tumor vasculature measured by CTP on the clinical outcome in bevacizumab-based chemotherapy measured by overall survival (OS)
Time frame: four years
Tumor vasculature at progression
Tumor vasculature measured by blood flow, blood volume, mean transit time and permeability surface-area product in CTP at the time of confirmed progression
Time frame: one year
Subgroup analyses according to the RAS mutation status, BRAF mutation status and VEGF-A level
Predictive power of RAS-mutation status, BRAF-mutation status and VEGF-A level on the clinical outcome in bevacizumab-based chemotherapy measured by progression-free survival (PFS)
Time frame: one year
Local and distant recurrences
Rates of local and distant recurrences according to RECIST 1.1 criteria
Time frame: one year
This study is terminated, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
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