Preoperative Imaging in Retroperitoneal Sarcoma
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Institute of Cancer Research, United Kingdom
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Prediction, by MRI, of early response to radiotherapy prior to tumour shrinkage
Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with retroperitoneal sarcomas planned for surgical resection +/- preoperative radiotherapy.
Exclusion Criteria
- •MRI incompatible metal implants
- •claustrophobia
Outcomes
Primary Outcomes
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
- To determine the reproducibility of multi-parametric MRI measurements within tumour regions of interest in patients with retroperitoneal sarcoma.(1-7 days)
Investigators
Nandita deSouza
Professor of Translational Imaging
Institute of Cancer Research, United Kingdom