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Completed

NCT Number: NCT00748891

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

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

London, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Recentin (Cediranib)

Drug

30mg once daily, oral dose

Other names: Cediranib

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Royal Marsden NHS Foundation Trust

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Sep 9, 2008
Registry last updated
Jul 1, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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