DCE CT/MRI Scanning Study in Patients With Solid Tumours (AstraZeneca and Royal Marsden Hospital Imaging Study)

Study Overview
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Brief Summary
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This study is being carried out in patients with advanced solid tumours to assess which of two different types of imaging scans best measures activity of an experimental drug called Cediranib. The study compares the imaging tests: Dynamic Contrast Enhanced CT (DCE-CT) and Dynamic Contrast Enhanced MRI (DCE-MRI). It looks at which of these scans is the most accurate and best predicts a response to the treatment. Cediranib is thought to work by stopping blood flow to cancers, and both of these scans assess blood flow. Studying the response of cancers by measuring changes in their blood flow may provide useful information that will guide the way we manage cancers in the future.

Official Title
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Exploratory Open-Label, Non-randomised, Single Centre Methodology Study Comparing DCE-CT and DCE-MRI as Markers of Changes in Vascular Activity Mediated by a Positive Control Agent [Cediranib (Recentin™; AZD2171), a Potent Inhibitor of VEGF-driven Angiogenesis] in Patients With Advanced Solid Tumour

Conditions
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Cancer

Intervention / Treatment
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* Drug: Recentin (Cediranib)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed metastatic tumour which is refractory to standard therapies At least one lesion size ≥3cm on in longest diameter suitable for repeat assessment by DCE-CT and DCE-MRI Patients must be able to undergo DCE-CT and DCE-MRI scanning procedures Life expectancy of at least 12 weeks Exclusion Criteria: Patients with hormone refractory prostate cancer (HRPC) Patients with a history of poorly controlled high blood pressure Ineligibility for MRI scanning or DCE-CT or DCE-MRI scanning

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Open label 30mg Cediranib administered once daily during scanning phase and if tolerated by patient, until disease progression | Drug: Recentin (Cediranib)<br>* 30mg once daily, oral dose<br>* Other names: Cediranib;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage change in DCE-MRI and DCE-CT vascular parameters. Comparison between vascular parameters of each imaging modality and between modalities. |  | DCE-MRI and DCE-CT scans taken at Baseline, Day 7 and Day 28. Comparison between modalities from scans taken on Days -8 and Day-1. | 
| Baseline measurements for DCE-MRI-iAUC60(mMol/sec),Ktrans(min-1),ve,vp,kep(min-1,Enhancing Fraction% DCE-CT-Permeability Surface Product(ml/min/100g),Perfusion(ml/min/100g),Mean Transit Time(sec),Blood Volume (ml/100g),Positive Enhancement Integral(Hus). |  | DCE-MRI and DCE-CT scans taken at Day -8, Day -1, Day 7 and Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective tumour response (RECIST )Progression free survival |  | RECIST scans within 4 weeks prior to first dose then 8 weekly up to 24 weeks, then 12 weekly thereafter | 
| Baseline and on treatment time-point measurements for iAUC60 (mMol/sec) and Positive Enhancement Integral (Hus) |  | DCE-MRI and DCE-CT scans taken at Day -8, Day -1, Day 7 and Day 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, tumour, advanced sold tumour, imaging, DCE-CT Scan, DCE-MRI scan, Cediranib, Recentin