- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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-
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London, Royaume-Uni
- Imperial College Healthcare NHS Trust
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Metastatic renal cell carcinoma
Patients with clear cell renal cell carcinoma treated with anti-angiogenic therapies
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Repeatability of Arterial Spin Label and Diffusion Weighted MRI parameters
Délai: At baseline MRI scan
|
At baseline MRI scan
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Changes in imaging parameters with treatment
Délai: 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
Délai: 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)
|
|
Correlation of imaging parameters with overall survival
Délai: 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)
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Nishat Bharwani, MRCP FRCR, Imperial College Healthcare NHS Trust
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 13SM0754
- 13/LO/1182 (Autre identifiant: REC Reference Number)
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