Visualization of Anti-angiogenic Effects With Perfusion Computed Tomography (CTP) (AVA-CTP)
15 december 2016 uppdaterad av: Patrick Veit-Haibach
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
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Förväntat)
50
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
GR
-
Chur, GR, Schweiz, 7000
- Kantonsspital Graubunden
-
-
LU
-
Luzern, LU, Schweiz, 6000
- Luzerner Kantonsspital
-
-
SG
-
St. Gallen, SG, Schweiz, 9007
- Kantonsspital St. Gallen
-
-
ZH
-
Winterthur, ZH, Schweiz, 8401
- Kantonsspital Winterthur
-
Zürich, ZH, Schweiz, 8091
- Universitätsspital Zürich
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Diagnostisk
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Övrig: 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
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
CTP as predictive marker for efficacy measured by progression-free survival
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
CTP as predictive marker for efficacy measured by progression-free survival
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: one year
|
Rates of local and distant recurrences according to RECIST 1.1 criteria
|
one year
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Patrick Veit-Haibach, MD, University Hospital Zurich, Diagnostic and Interventional Radiology
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 juli 2015
Primärt slutförande (Faktisk)
1 december 2016
Avslutad studie (Förväntat)
1 april 2017
Studieregistreringsdatum
Först inskickad
29 april 2015
Först inskickad som uppfyllde QC-kriterierna
27 juli 2015
Första postat (Uppskatta)
30 juli 2015
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
16 december 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
15 december 2016
Senast verifierad
1 december 2016
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- KEK-ZH-Nr. 2015-0084
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .