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A Study of Hypoxia Imaging in Advanced Pancreatic Cancer Patients Being Treated With Gemcitabine and TH-302 or TH-302 Placebo

14. februar 2018 opdateret af: University Health Network, Toronto

An Exploratory Study of Hypoxia Imaging Using 18F-FAZA-PET in Advanced Pancreatic Cancer Patients Being Treated With Gemcitabine + TH-302/Placebo (MAESTRO: EMR200592-001)

Researchers are looking for better ways of diagnosing and treating pancreatic cancer. It is believed that looking for low levels of oxygen (hypoxia) in tumours may give a better understanding of how certain tumours grow or respond to certain treatments. This study will look at hypoxia in pancreatic tumours while participants are receiving treatment with the combination of gemcitabine and TH-302/placebo in the EMR 200592-001 clinical research study.

This study will use positron emission tomography (PET) scans to look at hypoxia in tumours. PET is an imaging test that can be used to measure hypoxia in tumours. For this study, a radioactive tracer called Fluoroazomycin Arabinoside (FAZA) will be used to "label" areas of hypoxia in tumours. Determining the levels of hypoxia in tumour tissue using FAZA-PET scans and comparing these levels with the patient's response to treatment with gemcitabine and TH-302/placebo for pancreatic cancer may help the researchers to determine the relationship between hypoxia and response to this treatment.

The main purpose of this study is to see how useful looking at hypoxia in tumours are when they are done at different centres.

Studieoversigt

Status

Trukket tilbage

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Fase

  • Ikke anvendelig

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:

  • Have consented to participating on the first-line Gemcitabine + TH-302/placebo (study number EMR200592-001) study
  • Age 18 years or older
  • Cytologic/histologic diagnosis of pancreatic adenocarcinoma
  • Advanced stage pancreatic cancer: locally advanced or metastatic.
  • No prior chemotherapy for advanced/metastatic disease. Adjuvant chemotherapy allowed if completed > 6mths from study entry. Prior radio-sensitizing doses of 5-FU or gemcitabine also allowed.
  • ECOG performance status 1 or less
  • Adequate end organ and marrow function
  • Measureable or non-measureable disease by RECIST 1.1
  • Female patients of child-bearing potential must have a negative serum pregnancy test (BhCG) and must agree to abstinence or use adequate contraception for the duration of the study
  • Disease-free period of more than 5 years from prior malignancies other than pancreas (except curatively treated basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix and ductal carcinoma in situ (DCIS) breast disease).
  • Ability to provide written informed consent
  • Must be able to lie flat comfortably for 30 to 60 min to complete imaging study

Exclusion Criteria:

  • Inability to lie supine for 30 to 60 minutes
  • Concurrent second primary
  • Life expectancy of less than 12 weeks
  • On treatment with disulfiram (antabuse) due to [18F]FAZA injection containing up to 10% (v/v) ethanol in PBS (phosphate-buffered saline)

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: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: FAZA PET-CT scan

FAZA PET-CT imaging within 14 days of treatment from the EMR200592-001 study.

FAZA PET-CT imaging about 5 weeks after start of treatment from the EMR200592-001 study.
Medicin: 18F-Fluoroazomycin arabinoside
Andre navne:
  • 18F-FAZA
  • [18F] FAZA

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Expected number of similar quality scans produced compared to actual number of similar quality scans produced using the same method is less than 15%.
Tidsramme: 2 years
2 years
Number of enrolled patients that complete all required scans compared to total number of patients enrolled in the study is at least 70%.
Tidsramme: 2 years
2 years
Range of tumor hypoxia in patients with pancreatic cancer that had not received prior treatment.
Tidsramme: 2 years
2 years

Sekundære resultatmål

Resultatmål
Tidsramme
Compare the changes in tumor hypoxia before chemotherapy treatments and after chemotherapy treatments.
Tidsramme: 2 years
2 years
Compare the changes in tumor hypoxia with response to chemotherapy treatments.
Tidsramme: 2 years
2 years
Evaluate how FAZA is taken in by different tumor types within individual patients.
Tidsramme: 2 years
2 years

Samarbejdspartnere og efterforskere

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

Sponsor

University Health Network, Toronto

Samarbejdspartnere

Merck Frosst Canada Ltd.

Efterforskere

  • Ledende efterforsker: Neesha Dhani, M.D., Princess Margaret Cancer Centre

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 (Faktiske)

1. november 2014

Primær færdiggørelse (Faktiske)

1. november 2014

Studieafslutning (Faktiske)

1. november 2014

Datoer for studieregistrering

Først indsendt

28. maj 2014

Først indsendt, der opfyldte QC-kriterier

13. juli 2015

Først opslået (Skøn)

14. juli 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

19. februar 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. februar 2018

Sidst verificeret

1. februar 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Faza-Maestro

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 .

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Kliniske forsøg med 18F-Fluoroazomycin arabinoside

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner