- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02511756
Visualization of Anti-angiogenic Effects With Perfusion Computed Tomography (CTP) (AVA-CTP)
Visualization of Anti-angiogenic Effects With Perfusion Computed Tomography (CTP) in mCRC Patients Treated With First-line Bevacizumab
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
GR
-
Chur, GR, Switzerland, 7000
- Kantonsspital Graubünden
-
-
LU
-
Luzern, LU, Switzerland, 6000
- Luzerner Kantonsspital
-
-
SG
-
St. Gallen, SG, Switzerland, 9007
- Kantonsspital St. Gallen
-
-
ZH
-
Winterthur, ZH, Switzerland, 8401
- Kantonsspital Winterthur
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Zürich, ZH, Switzerland, 8091
- Universitätsspital Zürich
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age ≥ 18 years, male or female
- Signed written informed consent
- Patients with histologically confirmed diagnosis of colorectal cancer with hepatic metastases who are candidates for systemic treatment.
Confirmation of metastatic liver disease within one month prior to inclusion in one of the following radiological procedures:
- Contrast-enhanced spiral computed tomography showing at least one liver nodule ≥ 20 mm in longest diameter according to RECIST 1.1 criteria
- MR imaging of the liver with liver lesions suspicious for metastases
- PET computed tomography (PET/CT) with liver lesions suspicious for metastases
- Patient is eligible and designated for treatment with standard-of-care first-line bevacizumab-containing, fluoropyrimidine-based chemotherapy.
- ECOG performance status ≤ 2 (see appendix)
Exclusion Criteria:
- Inability or unwillingness to comply with the participation requirements
- History of untreated hyperthyreosis
- History of intolerance of or allergy to iodine contrast media according to CTCAE V4.03
- Calculated creatinine clearance < 45 ml/min
- For fertile women: positive urine pregnancy test or lactation.
- Known or suspected non-compliance, drug or alcohol abuse
- Life expectancy of less than 3 months
- Participation in another interventional trial with an investigational medicinal product (IMP) and within 30 days prior to screening
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Perfusion-computed tomography (CTP)
Patients undergo a total of four perfusion-computed tomographies from baseline to progression of disease.
|
Contrast-enhanced computed tomography of liver metastases
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CTP as predictive marker for efficacy measured by progression-free survival
Time Frame: one year
|
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)
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CTP as predictive marker for efficacy measured by progression-free survival
Time Frame: one year
|
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
|
one year
|
CTP as predictive marker for efficacy measured by overall survival
Time Frame: four years
|
Predictive power of decrease in tumor vasculature measured by CTP on the clinical outcome in bevacizumab-based chemotherapy measured by overall survival (OS)
|
four years
|
Tumor vasculature at progression
Time Frame: one year
|
Tumor vasculature measured by blood flow, blood volume, mean transit time and permeability surface-area product in CTP at the time of confirmed progression
|
one year
|
Subgroup analyses according to the RAS mutation status, BRAF mutation status and VEGF-A level
Time Frame: one year
|
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)
|
one year
|
Local and distant recurrences
Time Frame: one year
|
Rates of local and distant recurrences according to RECIST 1.1 criteria
|
one year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Patrick Veit-Haibach, MD, University Hospital Zurich, Diagnostic and Interventional Radiology
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KEK-ZH-Nr. 2015-0084
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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