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Preoperative Imaging in Retroperitoneal Sarcoma

Preoperative Imaging in Retroperitoneal Sarcoma

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01902667
Acronym
PIRS
Enrollment
32
Registered
2013-07-18
Start date
2013-07-31
Completion date
2017-06-30
Last updated
2018-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

Retroperitoneal Sarcoma, Magnetic Resonance Imaging

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.

Interventions

PROCEDUREMagnetic Resonance Imaging

Sponsors

Royal Marsden NHS Foundation Trust
CollaboratorOTHER
Cancer Research UK
CollaboratorOTHER
Institute of Cancer Research, United Kingdom
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* MRI incompatible metal implants * claustrophobia

Design outcomes

Primary

MeasureTime frameDescription
Prediction, by MRI, of early response to radiotherapy prior to tumour shrinkage2-4 weeksChanges 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

MeasureTime frameDescription
To determine the reproducibility of multi-parametric MRI measurements within tumour regions of interest in patients with retroperitoneal sarcoma.1-7 daysReproducibility 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

MeasureTime frameDescription
Correlation of imaging features with histopathological assessment of tumour size, local staging, cellularity, necrosis and viable tumour.2 monthsCorrelation 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).

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026