[18F]Fluciclatide PET Imaging of Pazopanib Response
27. februar 2016 oppdatert av: Jin-Sook Ryu, Asan Medical Center
Evaluation of [18F]FluciclatidePositron Emission Tomography For the Prediction of Response to Pazopanib In Patients With Metastatic Renal Cell Carcinoma: An Exploratory Study
Positron emission tomography (PET) is a non-invasive imaging tool for monitoring functional and metabolic responses of biological events with specific radiotracer in vivo.
The PET tracer [18F]Fluciclatide is an 18F radiolabeled small peptide containing the RGD (arginine-glycine-aspartate) tri-peptide, which preferentially binds with high affinity to αvβ3 and αvβ5 integrins.
αvβ3-integrins are expressed at low levels on epithelial cells and mature endothelial cells but are expressed at high levels on activated endothelial cells in the neo-vasculature of a range of tumors and it also may regulate angiogenesis.
If pazopanib acts mainly on active angiogenetic tumors, the quantitative uptake of [18F]Fluciclatide can be used to predict the effect of this antiangiogenic drug.
The investigators expected the baseline tumor uptake in [18F]Fluciclatide to be able to predict treatment response, and planned a study of [18F]FluciclatidePET for patients with metastatic RCC who received pazopanib systemic therapy.
Studieoversikt
Detaljert beskrivelse
Subjects will receive treatment with pazopanib at a dose of 800 mg orally once daily.
[18F]Fluciclatide imagings will be taken 2 times; 1) before systemic therapy (at baseline), 2) at one week after starting of Pazopanib.
However, If the target lesion on the baseline PET cannot be discriminated compared to the background activity, the 2nd PET will not be done.
Response evaluation by CT will be performed at baseline, at 6 week, at 12 week and every 8 weeks thereafter until the end of treatment.
RECIST1.1 criteria for response will be applied.
Patient will be treated with Pazopanib until there is disease progression, unacceptable toxicity or withdrawal of patient consent.
Studietype
Intervensjonell
Registrering (Faktiske)
12
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Songpa-gu
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Seoul, Songpa-gu, Korea, Republikken, 138-736
- Asan Medical Center
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
20 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Histologically confirmed renal cell carcinoma, stage IV patient.
- The tumor mass ≥1.5cm in diameter that is planned to receive Pazopanib as systemic antiangiogenic therapy.
- Pretreatment CT with or without contrast within 4 weeks prior to the first 18F-Fluciclatide PET scan.
- Evidence of unidimensionally measurable lesion(s) by RECIST criteria version 1.1.
- No prior systemic anti-angiogenic therapy for metastatic disease; prior antiangiogenic therapy used as an adjuvant therapy is allowed if it is completed 6 or more months before study enrollment.
- Male or female aged over 20 years
- Be ambulatory and have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Have a life expectancy of at least 3 months.
- Adequate medical condition in the judgment of the investigator
- Be willing and able to comply with the protocol for the duration of the study.
- Be willing and able to implement effective contraceptive practice
- Give written informed consent prior to study-specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.
Exclusion Criteria:
- Received another IMP within 30 days before the first administration of 18F-Fluciclatide injection.
- Inability to perform 18F-Fluciclatide PET imaging studies due to physical inability or claustrophobia.
- Intra-hepatic tumor only (without extra-hepatic tumor)
- Chemotherapy within 2weeks, or received radiotherapy to the region of the target lesion, surgery of target lesion within 2 weeks prior to the first 18F-Fluciclatide PET scan
- Pregnant, nursing women or patients with reproductive potential without contraception.
- Current treatment on another therapeutic clinical trial(except Pazopanib study)
- Any patients with known allergy to the GE health care product or any or its excipients should be excluded from the study
- Any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirements.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Drug; 18F-Fluciclatide
18F-Fluciclatide, 0.14 mCi/kg (not to exceed 10 mCi), IV(in the vein) administration
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Baseline 18F-Fluciclatide PET imaging will be obtained before starting of Pazopanib therapy(within 7 days). Subsequent 18F-Fluciclatide PET should be performed on 7 days after Pazopanib therapy
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Baseline 18F-Fluciclatide PET SUV
Tidsramme: Prior to starting Pazopanib treatment
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The difference of the baseline 18F-Fluciclatide PET SUV between responders and non-responders by RECIST criteria after Pazopanib therapy
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Prior to starting Pazopanib treatment
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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The difference of 18F-Fluciclatide PET parameters (% change of SUV) between responders and non-responders by RECIST criteria
Tidsramme: 7±1 days after Pazopanib treatment
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7±1 days after Pazopanib treatment
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Progression free survival more than 6 month
Tidsramme: More than 6 month after 1st PET scan
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Progression free survival defined as time from PET scan to the date of death, recurrence or progression
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More than 6 month after 1st PET scan
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Jin-Sook Ryu, MD. PhD., Asan Medical Center
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. september 2013
Primær fullføring (Forventet)
1. april 2016
Studiet fullført (Forventet)
1. april 2016
Datoer for studieregistrering
Først innsendt
7. oktober 2013
Først innsendt som oppfylte QC-kriteriene
10. oktober 2013
Først lagt ut (Anslag)
11. oktober 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
1. mars 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
27. februar 2016
Sist bekreftet
1. februar 2016
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2013-0382
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