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Completed

NCT Number: NCT01902667

Preoperative Imaging in Retroperitoneal Sarcoma

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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Key information

Conditions

Cancer Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Royal Marsden NHS Foundation Trust

Sutton, Surrey, SM2 5PT, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • MRI incompatible metal implants
  • claustrophobia

Treatment and study plan

Magnetic Resonance Imaging

Procedure

Primary outcomes

  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 outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Institute of Cancer Research, United Kingdom

Other

Collaborators

  • Cancer Research UK
  • Royal Marsden NHS Foundation Trust

Registry information

Acronym: PIRS

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Jul 18, 2013
Registry last updated
Aug 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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