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| Name | Class |
|---|---|
| Royal Marsden NHS Foundation Trust | OTHER |
| Cancer Research UK | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Curative intent surgery alone | Patients with retroperitoneal sarcoma randomised into surgery alone arm. |
| |
| Pre-operative radiotherapy plus surgery | Patients with retroperitoneal sarcoma randomised to Arm 2: pre-operative radiotherapy plus surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic Resonance Imaging | Procedure |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of imaging features with histopathological assessment of tumour size, local staging, cellularity, necrosis and viable tumour. | 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). |
Inclusion Criteria:
Exclusion Criteria:
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Patients with retroperitoneal sarcoma randomised for preoperative radiotherapy plus surgery versus surgery alone.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Royal Marsden NHS Foundation Trust | Sutton | Surrey | SM2 5PT | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31106141 | Derived | Winfield JM, Miah AB, Strauss D, Thway K, Collins DJ, deSouza NM, Leach MO, Morgan VA, Giles SL, Moskovic E, Hayes A, Smith M, Zaidi SH, Henderson D, Messiou C. Utility of Multi-Parametric Quantitative Magnetic Resonance Imaging for Characterization and Radiotherapy Response Assessment in Soft-Tissue Sarcomas and Correlation With Histopathology. Front Oncol. 2019 Apr 25;9:280. doi: 10.3389/fonc.2019.00280. eCollection 2019. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| 2 months |