Clinical trial NCT00748891: DCE CT/MRI Scanning Study in Patients With Solid Tumours (AstraZeneca and Royal Marsden Hospital Imaging Study)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer
Keywords: Cancer
tumour
advanced sold tumour
imaging
DCE-CT Scan
DCE-MRI scan
Cediranib
Recentin
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Royal Marsden NHS Foundation Trust
First posted: 2008-09-09
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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.


Eligibility 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

Primary outcomes:
measure: Percentage change in DCE-MRI and DCE-CT vascular parameters. Comparison between vascular parameters of each imaging modality and between modalities.
timeFrame: 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.
measure: 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).
timeFrame: DCE-MRI and DCE-CT scans taken at Day -8, Day -1, Day 7 and Day 28
Secondary outcomes:
measure: Objective tumour response (RECIST )Progression free survival
timeFrame: RECIST scans within 4 weeks prior to first dose then 8 weekly up to 24 weeks, then 12 weekly thereafter
measure: Baseline and on treatment time-point measurements for iAUC60 (mMol/sec) and Positive Enhancement Integral (Hus)
timeFrame: DCE-MRI and DCE-CT scans taken at Day -8, Day -1, Day 7 and Day 28
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca, Alderley Park
name: Jane Robertson, MD
role: STUDY_DIRECTOR
affiliation: Institute of Cancer Research, Royal Marsden Hospital
name: Johann De Bono, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Messiou C, Orton M, Ang JE, Collins DJ, Morgan VA, Mears D, Castellano I, Papadatos-Pastos D, Brunetto A, Tunariu N, Mann H, Tessier J, Young H, Ghiorghiu D, Marley S, Kaye SB, deBono JS, Leach MO, deSouza NM. Advanced solid tumors treated with cediranib: comparison of dynamic contrast-enhanced MR imaging and CT as markers of vascular activity. Radiology. 2012 Nov;265(2):426-36. doi: 10.1148/radiol.12112565. Epub 2012 Aug 13.