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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00748891
• Other study ID #: D1330C00003
• Secondary ID: EDRACT nbr 2007-
• Status: Completed
• Phase: Phase 1
• First received: September 5, 2008
• Last updated: June 30, 2011
• Start date: August 2008
• Est. completion date: November 2010

Study information

• Verified date: June 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: November 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• Recentin (Cediranib)
30mg once daily, oral dose

Locations

Country	Name	City	State
United Kingdom	Research Site	London

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Royal Marsden NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Primary	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	No
Secondary	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	No
Secondary	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	No