Visualization of Anti-angiogenic Effects With Perfusion Computed Tomography (CTP)

NCT ID: NCT02511756

Last Updated: 2016-12-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2017-04-30

Brief Summary

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

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.

Conditions

Metastatic Colorectal Cancer

Keywords

Perfusion-computed tomography

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Perfusion-computed tomography (CTP)

Patients undergo a total of four perfusion-computed tomographies from baseline to progression of disease.

Group Type: OTHER

Computed tomography X-ray system

Intervention Type: DEVICE

Contrast-enhanced computed tomography of liver metastases

Interventions

Computed tomography X-ray system

Contrast-enhanced computed tomography of liver metastases

Intervention Type: DEVICE

Other Intervention Names

CT scanner

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roche Pharma AG

INDUSTRY

Sponsor Role: collaborator

Patrick Veit-Haibach

OTHER

Sponsor Role: lead

Responsible Party

Patrick Veit-Haibach

PD MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Patrick Veit-Haibach, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Zurich, Diagnostic and Interventional Radiology

Locations

Luzerner Kantonsspital

Lucerne, Canton of Lucerne, Switzerland

Kantonsspital St. Gallen

Sankt Gallen, Canton of St. Gallen, Switzerland

Kantonsspital Winterthur

Winterthur, Canton of Zurich, Switzerland

Universitätsspital Zürich

Zurich, Canton of Zurich, Switzerland

Kantonsspital Graubünden

Chur, Kanton Graubünden, Switzerland

Countries

Switzerland

Other Identifiers

KEK-ZH-Nr. 2015-0084

Identifier Type: -

Identifier Source: org_study_id