Preoperative Imaging in Retroperitoneal Sarcoma

Completed

• Conditions: Cancer
• Interventions: Procedure: Magnetic Resonance Imaging

• Registration Number: NCT01902667
• Lead Sponsor: Institute of Cancer Research, United Kingdom

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-09
• Study First Submitted QC: 2013-07-16
• Study First Posted: 2013-07-18
• Primary Completion: 2017-06-30
• Study Completion: 2017-06-30
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-07
• Last Update Posted: 2018-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

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

Exclusion Criteria

• MRI incompatible metal implants
• claustrophobia

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Prediction, by MRI, of early response to radiotherapy prior to tumour shrinkage	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.

Secondary Outcome Measures

Name	Time	Method
To determine the reproducibility of multi-parametric MRI measurements within tumour regions of interest in patients with retroperitoneal sarcoma.	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.

Trial Locations

Locations (1)

The Royal Marsden NHS Foundation Trust; 🇬🇧 Sutton, Surrey, United Kingdom