- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01336452
Noninvasive Surrogate Marker for Advanced Hepatocellular Carcinoma Response to Concurrent Chemoradiotherapy: MR Perfusion, Contrast Enhanced Ultrasound and Biomarkers
1. juni 2013 opdateret af: Yonsei University
Hepatocellular carcinoma is the sixth most common malignancy and the third most common cause of cancer-related death worldwide.
The incidence of HCC is rising in Europe and the United States and is expected to continue to increase during the next 2 to 3 decades.
The expected survival rate is still decimal, especially in patients with advanced HCC.
However, in recent years, several treatment methods for patients with advanced HCC, including antiangiogenic chemotherapy, radiotherapy, concurrent chemoradiotherapy, and DC bead transarterial chemoembolization, have been developed.
Among these new treatment methods, concurrent chemoradiotherapy has also proved to increase patient's survival rate.
It is important to predict treatment response before treatment or immediately after treatment because there are several other treatment options as mentioned above.
Recently, there have been several reports that MR perfusion parameters such as Ktrans can predict treatment response in cervical cancer and colorectal cancer.
Therefore the purpose of the investigators study is to evaluate the feasibility of predicting treatment response by MR perfusion, contrast enhanced ultrasound parameters and biomarkers (IL-6, IL-12 and VEGF) in patients with advanced hepatocellular carcinoma who undertake concurrent chemoradiotherapy.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
30
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Seoul, Korea, Republikken, 120-752
- Rekruttering
- Severance Hospital
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Kontakt:
- Yong-Eun Chung, MD, Ph.D
- Telefonnummer: 82-2-2228-7400
- E-mail: radpms@yuhs.ac
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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
20 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Patients who have advanced hepatocellular carcinoma and plan to undertake concurrent chemoradiotherapy.
- Patients willing to undergo the study procedure
- Patients who are fully informed about the study and have signed the informed consent form
Exclusion Criteria:
- Patients (men or women) under 20 years of age
- Patients who have been received any other treatment including TACE, operation, TACI, systemic chemotherapy, intraarterial chemotherapy, antiangiogenic therapy
- Patients who have hypersensitivity to MR or US contrast agents
- Women who are pregnant, lactating or who are of childbearing potential and have not had a negative pregnancy test at baseline visit
- Patients not eligible to contrast media injection according to product labeling
- Patients with a contraindication for MRI or CT
- Patients with impaired renal function (e.g. acute renal failure) or patients on dialysis
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 |
---|---|
Andet: CCRTx
consecutive patients who plan to undertake CCRTx due to advanced hepatocellular carcinoma
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DCE (dynamic contrast enhanced) MRI will be obtained just before CCRTx and immediately after finishing CCRTx with 0.1mmol/kg of MR contrast media; CEUS will be obtained just before CCRTx, immediately after finishing CCRTx, and 1 month after CCRTx with 2.4 mL of SonoVue.
Blood sampling for biomarker analysis will be performed just before CCRTx, immediately after finishing CCRTx, and 1 month after CCRTx (20mL)
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
characteristic of Perfusion MR
Tidsramme: 1 month
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Ktrans (volume transfer constant between the EES and the blood plasma), Kep (rate constant between the EES and the blood plasma), Ve (Ktrnas/Kep: EES fractional volume), tumor volume
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1 month
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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. april 2011
Primær færdiggørelse (Forventet)
1. december 2013
Studieafslutning (Forventet)
1. december 2013
Datoer for studieregistrering
Først indsendt
13. april 2011
Først indsendt, der opfyldte QC-kriterier
14. april 2011
Først opslået (Skøn)
15. april 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
4. juni 2013
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. juni 2013
Sidst verificeret
1. juni 2013
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 4-2010-0566
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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