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

15. december 2016 opdateret af: 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

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

50

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Schweiz
    • GR
      • Chur, GR, Schweiz, 7000
        • Kantonsspital Graubünden
    • 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
        • Universitatsspital Zurich

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: Perfusion-computed tomography (CTP)
Patients undergo a total of four perfusion-computed tomographies from baseline to progression of disease.
Enhed: Computed tomography X-ray system
Contrast-enhanced computed tomography of liver metastases
Andre navne:
  • CT-scanner

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
CTP as predictive marker for efficacy measured by progression-free survival
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
CTP as predictive marker for efficacy measured by progression-free survival
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: one year
Rates of local and distant recurrences according to RECIST 1.1 criteria
one year

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Patrick Veit-Haibach

Samarbejdspartnere

Roche Pharma AG

Efterforskere

  • Ledende efterforsker: Patrick Veit-Haibach, MD, University Hospital Zurich, Diagnostic and Interventional Radiology

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juli 2015

Primær færdiggørelse (Faktiske)

1. december 2016

Studieafslutning (Forventet)

1. april 2017

Datoer for studieregistrering

Først indsendt

29. april 2015

Først indsendt, der opfyldte QC-kriterier

27. juli 2015

Først opslået (Skøn)

30. juli 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

16. december 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. december 2016

Sidst verificeret

1. december 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • KEK-ZH-Nr. 2015-0084

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Metastatisk tyktarmskræft

Kliniske forsøg med Computed tomography X-ray system

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

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CROs in Macedonia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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