Preoperative Imaging in Retroperitoneal Sarcoma

Study Overview
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Brief Summary
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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.

Official Title
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Preoperative Imaging in Retroperitoneal Sarcoma

Conditions
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Cancer

Intervention / Treatment
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* Procedure: Magnetic Resonance Imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with retroperitoneal sarcomas planned for surgical resection +/- preoperative radiotherapy. Exclusion Criteria: MRI incompatible metal implants claustrophobia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prediction, by MRI, of early response to radiotherapy prior to tumour shrinkage | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Retroperitoneal Sarcoma, Magnetic Resonance Imaging