PERfusion CT in the FOXFIRE Trial to Study Blood Flow to Liver Metastases (PERFORM)

June 19, 2012 updated by: University of Oxford

Perfusion Computed Tomography Pilot Study in the NCRN FOXFIRE Clinical Trial to Determine Blood Flow to Liver Metastases

The PERFORM study is a pilot study investigating the feasibility and usefulness of performing a novel CT (Computed Tomography)scanning technique called Perfusion CT(CTP) as an addition to normal CT scanning in patients recruited to the FOXFIRE trial. All patients recruited to FOXFIRE at the Oxford Radcliffe Hospitals and University Hospitals of Leicester will be invited to take part. FOXFIRE is a national randomised controlled trial in which patients with unresectable liver tumours secondary to colorectal cancer will receive treatment with standard chemotherapy alone, or with chemotherapy in combination with an internal radiotherapy treatment which delivers radioactive particles(SIR-spheres) to the liver via its own blood supply (radioembolisation). In the FOXFIRE study a normal CT scan would usually be performed prior to the start of treatment and also three months after the commencement of treatment to assess the cancer's response to treatment, particularly whether the tumour has changed in size as a result of treatment. Perfusion CT gives the normal information on changes in tumour size but also assesses whether the blood flow to the cancer has changed, which may allow earlier identification of treatment success compared to normal CT scans. All patients consenting to participate in the PERFORM study will undergo four perfusion CT scans: one before the treatment starts, and one at the start of each of the second, third and fifth cycles of chemotherapy. The aim is to determine the feasibility of measuring tumour perfusion for data analysis using perfusion CT and to establish if the tumour perfusion pattern at baseline or shortly after the start of therapy can predict response to radioembolisation or chemotherapy. This research is funded by the National Institute for Health Research Biomedical Research Centre in Oxford and Oxfordshire Health Services Research Committee.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Oxford, United Kingdom, OX3 7LJ
        • Recruiting
        • Oxford Radcliffe Hospitals NHS Trust
        • Contact:
        • Sub-Investigator:
          • Esme J Hill, MBChB

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who have given written informed consent to participate in the FOXFIRE clinical trial and have not yet started chemotherapy treatment in the trial.
  • Serum creatinine and calculated glomerular filtration rate are less than the upper limit of normal (ULN) in blood tests performed up to 29 days before entry into the FOXFIRE clinical trial.
  • Liver metastasis 1.0 to4.0 cm in cranio-caudal diameter on imaging performed up to 29 days before entry into the FOXFIRE clinical trial

Exclusion Criteria:

  • True allergy to intravenous iodinated CT contrast
  • Active medical or psychological illness that would render the patient unsuitable for the additional imaging proposed in this pilot study, at the discretion of the investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recruitment rate to this voluntary study and acquisition of sufficient data for perfusion analysis
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Correlation between the tumour perfusion pattern on perfusion CT studies at baseline and shortly after the start of therapy and morphological response by RECIST criteria on CT scan 3 months post therapy in both arms of the FOXFIRE trial.
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oxford

Collaborators

University Hospitals, Leicester
Oxford University Hospitals NHS Trust

Investigators

  • Principal Investigator: Ricky A Sharma, MB BChir, University of Oxford

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Anticipated)

April 1, 2013

Study Registration Dates

First Submitted

August 3, 2011

First Submitted That Met QC Criteria

August 4, 2011

First Posted (Estimate)

August 5, 2011

Study Record Updates

Last Update Posted (Estimate)

June 20, 2012

Last Update Submitted That Met QC Criteria

June 19, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10/H0505/95

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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