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

This study has been completed.
Sponsor:
Collaborator:
Royal Marsden NHS Foundation Trust
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00748891
First received: September 5, 2008
Last updated: June 30, 2011
Last verified: June 2011
  Purpose

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 Intervention Phase
Cancer
Drug: Recentin (Cediranib)
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 35
Study Start Date: August 2008
Study Completion Date: November 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00748891

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

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Nick Botwood BSc, MBBS, MRCP, MFPM, Medical Science DirectoR, RECENTIN, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00748891     History of Changes
Other Study ID Numbers: D1330C00003, EDRACT nbr 2007-006251-39
Study First Received: September 5, 2008
Last Updated: June 30, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:
Cancer
tumour
advanced sold tumour
imaging
DCE-CT Scan
DCE-MRI scan
Cediranib
Recentin

ClinicalTrials.gov processed this record on July 28, 2014