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

Primary Purpose

Metastatic Colorectal Cancer

Status
Terminated
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Computed tomography X-ray system
Sponsored by
Patrick Veit-Haibach
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Metastatic Colorectal Cancer focused on measuring Perfusion-computed tomography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kantonsspital Graubünden
  • Luzerner Kantonsspital
  • Kantonsspital St. Gallen
  • Kantonsspital Winterthur
  • Universitätsspital Zürich

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Perfusion-computed tomography (CTP)

Arm Description

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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
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)
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
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)
Local and distant recurrences
Rates of local and distant recurrences according to RECIST 1.1 criteria

Full Information

First Posted
April 29, 2015
Last Updated
December 15, 2016
Sponsor
Patrick Veit-Haibach
Collaborators
Roche Pharma AG
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1. Study Identification

Unique Protocol Identification Number
NCT02511756
Brief Title
Visualization of Anti-angiogenic Effects With Perfusion Computed Tomography (CTP)
Acronym
AVA-CTP
Official Title
Visualization of Anti-angiogenic Effects With Perfusion Computed Tomography (CTP) in mCRC Patients Treated With First-line Bevacizumab
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Terminated
Why Stopped
Slow accrual
Study Start Date
July 2015 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
April 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Patrick Veit-Haibach
Collaborators
Roche Pharma AG

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Cancer
Keywords
Perfusion-computed tomography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Perfusion-computed tomography (CTP)
Arm Type
Other
Arm Description
Patients undergo a total of four perfusion-computed tomographies from baseline to progression of disease.
Intervention Type
Device
Intervention Name(s)
Computed tomography X-ray system
Other Intervention Name(s)
CT scanner
Intervention Description
Contrast-enhanced computed tomography of liver metastases
Primary Outcome Measure Information:
Title
CTP as predictive marker for efficacy measured by progression-free survival
Description
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
Secondary Outcome Measure Information:
Title
CTP as predictive marker for efficacy measured by progression-free survival
Description
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
Title
CTP as predictive marker for efficacy measured by overall survival
Description
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
Title
Tumor vasculature at progression
Description
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
Title
Subgroup analyses according to the RAS mutation status, BRAF mutation status and VEGF-A level
Description
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
Title
Local and distant recurrences
Description
Rates of local and distant recurrences according to RECIST 1.1 criteria
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Veit-Haibach, MD
Organizational Affiliation
University Hospital Zurich, Diagnostic and Interventional Radiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kantonsspital Graubünden
City
Chur
State/Province
GR
ZIP/Postal Code
7000
Country
Switzerland
Facility Name
Luzerner Kantonsspital
City
Luzern
State/Province
LU
ZIP/Postal Code
6000
Country
Switzerland
Facility Name
Kantonsspital St. Gallen
City
St. Gallen
State/Province
SG
ZIP/Postal Code
9007
Country
Switzerland
Facility Name
Kantonsspital Winterthur
City
Winterthur
State/Province
ZH
ZIP/Postal Code
8401
Country
Switzerland
Facility Name
Universitätsspital Zürich
City
Zürich
State/Province
ZH
ZIP/Postal Code
8091
Country
Switzerland

12. IPD Sharing Statement

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

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