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

NCT02511756 | Terminated

• 1 other identifier: KEK-ZH-Nr. 2015-0084
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 5

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

Conditions

Metastatic Colorectal Cancer

Keywords

Perfusion-computed tomography

Outcome Measures

Primary Outcomes (1)

• 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)

  one year

Secondary Outcomes (5)

• CTP as predictive marker for efficacy measured by progression-free survival

  one year

• CTP as predictive marker for efficacy measured by overall survival

  four years

• Tumor vasculature at progression

  one year

• Subgroup analyses according to the RAS mutation status, BRAF mutation status and VEGF-A level

  one year

• Local and distant recurrences

  one year

Study Arms (1)

Perfusion-computed tomography (CTP)

OTHER

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

Device: Computed tomography X-ray system

Interventions

Computed tomography X-ray system DEVICE

Contrast-enhanced computed tomography of liver metastases

Also known as: CT scanner

Perfusion-computed tomography (CTP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Patrick Veit-Haibach: lead
• Roche Pharma AG: collaborator

Study Sites (5)

Luzerner Kantonsspital

Lucerne, Canton of Lucerne, 6000, Switzerland

Location

Kantonsspital St. Gallen

Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

Location

Kantonsspital Winterthur

Winterthur, Canton of Zurich, 8401, Switzerland

Location

Universitätsspital Zürich

Zurich, Canton of Zurich, 8091, Switzerland

Location

Kantonsspital Graubünden

Chur, Kanton Graubünden, 7000, Switzerland

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Tomography Scanners, X-Ray Computed

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Patrick Veit-Haibach, MD

  University Hospital Zurich, Diagnostic and Interventional Radiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PD MD

Study Record Dates

• First Submitted: April 29, 2015
• First Posted: July 30, 2015
• Study Start: July 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: April 1, 2017
• Last Updated: December 16, 2016

Record last verified: 2016-12

Locations

CH (5)