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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00748891
Recruitment Status : Completed
First Posted : September 9, 2008
Last Update Posted : July 1, 2011
Royal Marsden NHS Foundation Trust
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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.

Condition or disease Intervention/treatment Phase
Cancer Drug: Recentin (Cediranib) Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: 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
Study Start Date : August 2008
Actual Primary Completion Date : February 2010
Actual Study Completion Date : November 2010

Arm Intervention/treatment
Experimental: 1
Open label 30mg Cediranib administered once daily during scanning phase and if tolerated by patient, until disease progression
Drug: Recentin (Cediranib)
30mg once daily, oral dose
Other Name: Cediranib

Primary Outcome Measures :
  1. Percentage change in DCE-MRI and DCE-CT vascular parameters. Comparison between vascular parameters of each imaging modality and between modalities. [ Time Frame: 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. ]
  2. 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). [ Time Frame: DCE-MRI and DCE-CT scans taken at Day -8, Day -1, Day 7 and Day 28 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00748891

United Kingdom
Research Site
London, United Kingdom
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Study Director: Jane Robertson, MD AstraZeneca, Alderley Park
Principal Investigator: Johann De Bono, MD Institute of Cancer Research, Royal Marsden Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr Nick Botwood BSc, MBBS, MRCP, MFPM, Medical Science DirectoR, RECENTIN, AstraZeneca Pharmaceuticals Identifier: NCT00748891     History of Changes
Other Study ID Numbers: D1330C00003
EDRACT nbr 2007-006251-39
First Posted: September 9, 2008    Key Record Dates
Last Update Posted: July 1, 2011
Last Verified: June 2011

Keywords provided by AstraZeneca:
advanced sold tumour
DCE-MRI scan

Additional relevant MeSH terms:
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action