Preoperative Imaging in Retroperitoneal Sarcoma

NCT01902667 | Completed

• 1 other identifier: 13/EE/0186 CCR3992
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

Retroperitoneal Sarcoma; Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• To determine the reproducibility of multi-parametric MRI measurements within tumour regions of interest in patients with retroperitoneal sarcoma.

  1-7 days

Other Outcomes (1)

• Correlation of imaging features with histopathological assessment of tumour size, local staging, cellularity, necrosis and viable tumour.

  2 months

Study Arms (2)

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

Interventions

Magnetic Resonance Imaging PROCEDURE

Curative intent surgery alone; Pre-operative radiotherapy plus surgery

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with retroperitoneal sarcoma randomised for preoperative radiotherapy plus surgery versus surgery alone.

You may qualify if:

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

You may not qualify if:

• MRI incompatible metal implants
• claustrophobia

Sponsors & Collaborators

• Institute of Cancer Research, United Kingdom: lead
• Royal Marsden NHS Foundation Trust: collaborator
• Cancer Research UK: collaborator

Study Sites (1)

The Royal Marsden NHS Foundation Trust

Sutton, Surrey, SM2 5PT, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 31106141 DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Translational Imaging

Study Record Dates

• First Submitted: July 9, 2013
• First Posted: July 18, 2013
• Study Start: July 1, 2013
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2017
• Last Updated: August 8, 2018

Record last verified: 2018-08

Locations

GB (1)