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

Phase 1

Completed

• Conditions: Cancer
• Interventions: Drug: Recentin (Cediranib)

• Registration Number: NCT00748891
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-09-05
• Study First Submitted QC: 2008-09-08
• Study First Posted: 2008-09-09
• Primary Completion: 2010-02
• Study Completion: 2010-11
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-30
• Last Update Posted: 2011-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Recentin (Cediranib)	Open label 30mg Cediranib administered once daily during scanning phase and if tolerated by patient, until disease progression

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇬🇧 London, United Kingdom