Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Functional Imaging in the Assessment of mRCC Response to Sunitinib

20. november 2015 opdateret af: Imperial College Healthcare NHS Trust

Pilot Study to Evaluate the Feasibility of Functional MRI in Metastatic Renal Cell Carcinoma (mRCC) With Test--retest Repeatability and Early Response Assessment

The aim of this study is to assess whether functional magnetic resonance imaging (MRI) techniques are able to detect which patients with metastatic renal cell carcinoma will derive benefit from treatment with anti-angiogenic drugs early in their treatment. Early response assessment would allow selection of the most appropriate treatment option for each individual patient.

Studieoversigt

Status

Trukket tilbage

Detaljeret beskrivelse

Renal cell carcinoma (RCC) is a highly vascularized tumour that is dependent on new vessel formation (angiogenesis) for growth and spread beyond the kidney (metastases). In recent years a new class of drugs have been developed which target the formation of this blood supply, stopping tumour growth and resulting in increased survival. These anti-angiogenic drugs such as Sunitinib, Pazopanib, Axitinib and Everolimus are now the standard of care in metastatic RCC (mRCC) in the United Kingdom.

Currently we assess if cancers are responding to treatment by looking at changes in the size of the tumour and metastases using computed tomography. However, the positive effects of drugs such as sunitinib do not always show a change in size, particularly early in treatment. Therefore we need to develop alternative methods for assessing if patients are responding in order to optimise individual management plans and prevent unnecessary toxicity and cost.

The aim of this study is to assess if three different functional magnetic resonance imaging (MRI) techniques are able to predict which patients will derive benefit from anti-angiogenic therapy early in their treatment. The study will recruit patients with mRCC who are going to be treated with anti-angiogenic drugs. These patients will have an MRI scan before they commence treatment and then a further scan after one treatment cycle (4 weeks) in addition to their normal clinical follow-up. The sequences being evaluated (arterial spin labeling, diffusion-weighted imaging and dynamic contrast imaging) look at the blood supply to the cancer and it is expected that there will be different changes in this blood supply in patients who are benefiting from treatment compared to those who are not responding. Early knowledge of response will help doctors choose the most appropriate treatment option for each individual patient.

Consenting patients with treatment naïve metastatic clear cell RCC will be recruited to the study. Before commencing anti-angiogenic therapy, patients will undergo 3 Tesla MRI covering the primary tumour or largest metastatic deposit identified from their staging CT examination if prior nephrectomy has been performed. Following 4 weeks of therapy (one treatment cycle), patients will undergo repeat MR imaging using the same protocol.

Undersøgelsestype

Interventionel

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

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:

  • Patients with newly diagnosed (i.e. treatment naive) metastatic clear cell renal cell carcinoma judged by their treating physician to have the potential to derive benefit from anti-angiogenic therapy
  • Histopathologically confirmed clear cell renal cell carcinoma
  • Male or female aged 18 years or older

Exclusion Criteria:

  • Previous medical treatment for renal cancer
  • Cardiac pacemaker or other contra-indication to magnetic resonance imaging
  • Contra-indication to intravenous Gadolinium
  • Pregnancy or breastfeeding

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: Metastatic renal cell carcinoma
Patients with clear cell renal cell carcinoma treated with anti-angiogenic therapies

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
To determine if functional MRI techniques are able to detect treatment-related changes in patients with metastatic renal cell carcinoma treated with sunitinib
Tidsramme: At baseline and following one treatment cycle (expected 4 weeks) with anti-angiogenic therapy
At baseline and following one treatment cycle (expected 4 weeks) with anti-angiogenic therapy

Sekundære resultatmål

Resultatmål
Tidsramme
Repeatability of Arterial Spin Label and Diffusion Weighted MRI parameters
Tidsramme: At baseline MRI scan
At baseline MRI scan
Changes in imaging parameters with treatment
Tidsramme: At baseline and following one treatment cycle (expected 4 weeks) with anti-angiogenic therapy
At baseline and following one treatment cycle (expected 4 weeks) with anti-angiogenic therapy
Correlation of imaging parameters with progression free survival
Tidsramme: Time from study enrolment to progression assessed by RECIST v1.1 on computed tomography performed after every three treatment cycles (up to 36 months)
Time from study enrolment to progression assessed by RECIST v1.1 on computed tomography performed after every three treatment cycles (up to 36 months)
Correlation of imaging parameters with overall survival
Tidsramme: Time from study enrolment to date of death from any cause (up to 36 months)
Time from study enrolment to date of death from any cause (up to 36 months)

Samarbejdspartnere og efterforskere

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

Efterforskere

  • Ledende efterforsker: Nishat Bharwani, MRCP FRCR, Imperial College Healthcare NHS Trust

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 2014

Primær færdiggørelse (Faktiske)

1. august 2015

Studieafslutning (Faktiske)

1. august 2015

Datoer for studieregistrering

Først indsendt

30. september 2013

Først indsendt, der opfyldte QC-kriterier

31. oktober 2013

Først opslået (Skøn)

6. november 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

23. november 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. november 2015

Sidst verificeret

1. august 2015

Mere information

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 nyrecellekarcinom

Kliniske forsøg med Magnetisk resonansbilleddannelse (MRI)

Abonner