Preoperative Imaging in Retroperitoneal Sarcoma (PIRS)

August 7, 2018 updated by: Nandita deSouza, Institute of Cancer Research, United Kingdom

This is a prospective observational study in which patients with untreated retroperitoneal sarcoma will have Magnetic Resonance Imaging (MRI) prior to surgery. In addition, patients who will be undergoing pre-operative radiotherapy will have an additional MRI scan at two weeks post radiotherapy. For both groups, the magnetic resonance images will be correlated with tumour pathology.

The study hypothesis is that Magnetic Resonance Imaging will provide a more accurate assessment of tumour volume and local staging than CT and will identify areas of altered oxygenation, cellularity and perfusion which change in response to radiotherapy before tumour shrinkage occurs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

32

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
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • The Royal Marsden NHS Foundation Trust

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

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with retroperitoneal sarcoma randomised for preoperative radiotherapy plus surgery versus surgery alone.

Description

Inclusion Criteria:

  • Patients with retroperitoneal sarcomas planned for surgical resection +/- preoperative radiotherapy.

Exclusion Criteria:

  • MRI incompatible metal implants
  • claustrophobia

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Curative intent surgery alone
Patients with retroperitoneal sarcoma randomised into surgery alone arm.
Procedure: Magnetic Resonance Imaging
Pre-operative radiotherapy plus surgery
Patients with retroperitoneal sarcoma randomised to Arm 2: pre-operative radiotherapy plus surgery.
Procedure: Magnetic Resonance Imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prediction, by MRI, of early response to radiotherapy prior to tumour shrinkage
Time Frame: 2-4 weeks
Changes in volume, maximum axial diameter, ADC, F, D, D*, T2, R2* and enhancing fraction from baseline to post radiotherapy will be presented. A paired T-test (or Wilcoxon Signed Rank Test) may be used to test the difference between baseline and post radiotherapy. Differences in these values will be presented for responders and non-responders, which will be tested by independent T-test. Response will be determined by tumour size, enhancing fraction and histopathological evidence of response.
2-4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine the reproducibility of multi-parametric MRI measurements within tumour regions of interest in patients with retroperitoneal sarcoma.
Time Frame: 1-7 days
Reproducibility of the parameter ADC-Apparent Diffusion Coefficient (also F, D, D*, T2 and R2* values)between the two scans at baseline (within 7 days of each other)will be assessed using the Bland Altman method.
1-7 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of imaging features with histopathological assessment of tumour size, local staging, cellularity, necrosis and viable tumour.
Time Frame: 2 months
Correlation between the ADC (and D) and %ki 67 uptake, % necrosis, %fat content, % of viable tumour, % hyalinization/fibrosis, % dedifferentiated component, cellularity and stroma morphology will be assessed using the Pearson's correlation coefficient or the Spearman's (whichever is appropriate).
2 months

Collaborators and Investigators

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

Sponsor

Institute of Cancer Research, United Kingdom

Collaborators

Royal Marsden NHS Foundation Trust
Cancer Research UK

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

July 1, 2013

Primary Completion (Actual)

June 30, 2017

Study Completion (Actual)

June 30, 2017

Study Registration Dates

First Submitted

July 9, 2013

First Submitted That Met QC Criteria

July 16, 2013

First Posted (Estimate)

July 18, 2013

Study Record Updates

Last Update Posted (Actual)

August 8, 2018

Last Update Submitted That Met QC Criteria

August 7, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13/EE/0186 CCR3992

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.

Clinical Trials on Cancer

Clinical Trials on Magnetic Resonance Imaging

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burundi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe