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

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00748891

Collaborator

Royal Marsden NHS Foundation Trust (Other)

Enrollment

Location

Arm

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

Anticipated Enrollment :

35 participants

Allocation:

N/A

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 :

Aug 1, 2008

Actual Primary Completion Date :

Feb 1, 2010

Actual Study Completion Date :

Nov 1, 2010

Arms and Interventions

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 Names: Cediranib

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 Names:

Cediranib

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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