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- Klinische proef NCT01977586
Functional Imaging in the Assessment of mRCC Response to Sunitinib
Pilot Study to Evaluate the Feasibility of Functional MRI in Metastatic Renal Cell Carcinoma (mRCC) With Test--retest Repeatability and Early Response Assessment
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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London, Verenigd Koninkrijk
- Imperial College Healthcare NHS Trust
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Diagnostisch
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Metastatic renal cell carcinoma
Patients with clear cell renal cell carcinoma treated with anti-angiogenic therapies
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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To determine if functional MRI techniques are able to detect treatment-related changes in patients with metastatic renal cell carcinoma treated with sunitinib
Tijdsspanne: At baseline and following one treatment cycle (expected 4 weeks) with anti-angiogenic therapy
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At baseline and following one treatment cycle (expected 4 weeks) with anti-angiogenic therapy
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Repeatability of Arterial Spin Label and Diffusion Weighted MRI parameters
Tijdsspanne: At baseline MRI scan
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At baseline MRI scan
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Changes in imaging parameters with treatment
Tijdsspanne: At baseline and following one treatment cycle (expected 4 weeks) with anti-angiogenic therapy
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At baseline and following one treatment cycle (expected 4 weeks) with anti-angiogenic therapy
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Correlation of imaging parameters with progression free survival
Tijdsspanne: Time from study enrolment to progression assessed by RECIST v1.1 on computed tomography performed after every three treatment cycles (up to 36 months)
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Time from study enrolment to progression assessed by RECIST v1.1 on computed tomography performed after every three treatment cycles (up to 36 months)
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Correlation of imaging parameters with overall survival
Tijdsspanne: Time from study enrolment to date of death from any cause (up to 36 months)
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Time from study enrolment to date of death from any cause (up to 36 months)
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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Nishat Bharwani, MRCP FRCR, Imperial College Healthcare NHS Trust
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 13SM0754
- 13/LO/1182 (Andere identificatie: REC Reference Number)
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