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Preoperative Imaging in Retroperitoneal Sarcoma (PIRS)

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ClinicalTrials.gov Identifier: NCT01902667
Recruitment Status : Completed
First Posted : July 18, 2013
Last Update Posted : August 8, 2018
Sponsor:
Collaborators:
Royal Marsden NHS Foundation Trust
Cancer Research UK
Information provided by (Responsible Party):
Nandita deSouza, 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.


Condition or disease Intervention/treatment
Cancer Procedure: Magnetic Resonance Imaging

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Study Type : Observational
Actual Enrollment : 32 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Preoperative Imaging in Retroperitoneal Sarcoma
Actual Study Start Date : July 2013
Actual Primary Completion Date : June 30, 2017
Actual Study Completion Date : June 30, 2017


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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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).



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with retroperitoneal sarcoma randomised for preoperative radiotherapy plus surgery versus surgery alone.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • MRI incompatible metal implants
  • claustrophobia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01902667


Locations
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United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, United Kingdom, SM2 5PT
Sponsors and Collaborators
Institute of Cancer Research, United Kingdom
Royal Marsden NHS Foundation Trust
Cancer Research UK

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nandita deSouza, Professor of Translational Imaging, Institute of Cancer Research, United Kingdom
ClinicalTrials.gov Identifier: NCT01902667     History of Changes
Other Study ID Numbers: 13/EE/0186 CCR3992
First Posted: July 18, 2013    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018

Keywords provided by Nandita deSouza, Institute of Cancer Research, United Kingdom:
Retroperitoneal Sarcoma
Magnetic Resonance Imaging

Additional relevant MeSH terms:
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Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms