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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00748891

Enrollment

Registered

2008-09-09

Start date

2008-08-31

Completion date

2010-11-30

Last updated

2011-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

Cancer, tumour, advanced sold tumour, imaging, DCE-CT Scan, DCE-MRI scan, Cediranib, Recentin

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.

Interventions

DRUGRecentin (Cediranib)

30mg once daily, oral dose

Study design

Allocation

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026