A Study of Hypoxia Imaging in Advanced Pancreatic Cancer Patients Being Treated With Gemcitabine and TH-302 or TH-302 Placebo
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.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Fase
- Ikke aktuelt
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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. |
Andre navn:
|
Hva måler studien?
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
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Neesha Dhani, M.D., Princess Margaret Cancer Centre
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Faza-Maestro
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