Metastatic Colorectal CancerAVA-CTPNCT02511756
Visualization of Anti-angiogenic Effects With Perfusion Computed Tomography (CTP)
A study testing Computed tomography X-ray system in people with Metastatic Colorectal Cancer, run by Patrick Veit-Haibach at 5 sites in Switzerland.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- Computed tomography X-ray system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 5 sitesSwitzerland
- Study dates
- Jul 2015to Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Switzerland5 sites
Kantonsspital Graubünden
Chur, Kanton Graubünden, 7000
Luzerner Kantonsspital
Lucerne, Canton of Lucerne, 6000
Kantonsspital St. Gallen
Sankt Gallen, Canton of St. Gallen, 9007
Kantonsspital Winterthur
Winterthur, Canton of Zurich, 8401
Universitätsspital Zürich
Zurich, Canton of Zurich, 8091
About this study
Official title: Visualization of Anti-angiogenic Effects With Perfusion Computed Tomography (CTP) in mCRC Patients Treated With First-line Bevacizumab
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
Read the 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
- Being tested
- Computed tomography X-ray system
- Keywords
- Perfusion-computed tomography
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed tomography X-ray systemDevice
Also called CT scanner
Contrast-enhanced computed tomography of liver metastases
| Study group | Role | What they receive |
|---|---|---|
| Perfusion-computed tomography (CTP) | Other | Patients undergo a total of four perfusion-computed tomographies from baseline to progression of disease. Receives: Device: Computed tomography X-ray system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: one year
Secondary outcomes (5)
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
Measured: 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)
Measured: 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
Measured: 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)
Measured: one year
Local and distant recurrences
Rates of local and distant recurrences according to RECIST 1.1 criteria
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionDec 2016
- Study completionApr 2017 (estimated)
Why it stopped: Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Patrick Veit-Haibach
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG
- Responsible party
- Sponsor-investigator, Patrick Veit-Haibach, University of Zurich
- Investigators
- Patrick Veit-Haibach, MD, Principal investigator, University Hospital Zurich, Diagnostic and Interventional Radiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02511756
- Sponsor's protocol ID
- KEK-ZH-Nr. 2015-0084
- Acronym
- AVA-CTP
- Status last verified
- Dec 2016
- First submitted
- 29 Apr 2015
- Last updated
- 16 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visualization of Anti-angiogenic Effects With Perfusion Computed Tomography (CTP) in mCRC Patients Treated With First-line Bevacizumab
- ClinicalTrials.gov ID
- NCT02511756
- Acronym / sponsor ID
- AVA-CTP / KEK-ZH-Nr. 2015-0084
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- Perfusion-computed tomography
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Patrick Veit-HaibachUniversity, hospital or other
- Collaborators
- Roche Pharma AG
- Study start
- Jul 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Apr 2017 (estimated)
- First posted
- 30 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Perfusion-computed tomography (CTP) | Other | Device: Computed tomography X-ray systemPatients undergo a total of four perfusion-computed tomographies from baseline to progression of disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- Patient is eligible and designated for treatment with standard-of-care first-line bevacizumab-containing, fluoropyrimidine-based chemotherapy.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computed tomography X-ray systemAlso: CT scannerContrast-enhanced computed tomography of liver metastases | Device | Perfusion-computed tomography (CTP) |
Primary outcome
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)
5 secondary outcomes
CTP as predictive marker for efficacy measured by progression-free survival
Time frame: one year
CTP as predictive marker for efficacy measured by overall survival
Time frame: four years
Tumor vasculature at progression
Time frame: one year
Subgroup analyses according to the RAS mutation status, BRAF mutation status and VEGF-A level
Time frame: one year
Local and distant recurrences
Time frame: one year
Results and safety
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Veit-Haibach, MD principal investigator
University Hospital Zurich, Diagnostic and Interventional Radiology
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computed tomography X-ray system in people with Metastatic Colorectal Cancer, run by Patrick Veit-Haibach at 5 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CTP as predictive marker for efficacy measured by progression-free survival (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2016.