CancerPIRSNCT01902667
Preoperative Imaging in Retroperitoneal Sarcoma
An observational study of Cancer, run by Institute of Cancer Research, United Kingdom at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cancer
- What is being tested?
- Magnetic Resonance Imaging
- Type of treatment
- Surgery or procedure
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2013to 30 Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with retroperitoneal sarcoma randomised for preoperative radiotherapy plus surgery versus surgery alone.
Who may be able to join
- Patients with retroperitoneal sarcomas planned for surgical resection +/- preoperative radiotherapy.
Who cannot join
- MRI incompatible metal implants
- claustrophobia
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, SM2 5PT
About this study
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
- Being tested
- Magnetic Resonance Imaging
- Keywords
- Retroperitoneal Sarcoma, Magnetic Resonance Imaging
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance ImagingProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Curative intent surgery alone | Patients with retroperitoneal sarcoma randomised into surgery alone arm. Receives: Procedure: Magnetic Resonance Imaging | |
| Pre-operative radiotherapy plus surgery | Patients with retroperitoneal sarcoma randomised to Arm 2: pre-operative radiotherapy plus surgery. Receives: Procedure: Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 1-7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2013 (estimated)
- Study startJul 2013
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Cancer Research, United Kingdom
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Marsden NHS Foundation Trust, Cancer Research UK
- Responsible party
- Principal investigator, Nandita deSouza, Institute of Cancer Research, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01902667
- Sponsor's protocol ID
- 13/EE/0186 CCR3992
- Acronym
- PIRS
- Status last verified
- Aug 2018
- First submitted
- 9 Jul 2013
- Last updated
- 8 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31106141
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Imaging in Retroperitoneal Sarcoma
- ClinicalTrials.gov ID
- NCT01902667
- Acronym / sponsor ID
- PIRS / 13/EE/0186 CCR3992
- Conditions
- Cancer
- Keywords
- Retroperitoneal Sarcoma, Magnetic Resonance Imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Institute of Cancer Research, United KingdomUniversity, hospital or other
- Collaborators
- Royal Marsden NHS Foundation Trust, Cancer Research UK
- Study start
- Jul 2013 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 18 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Curative intent surgery alone | – | Procedure: Magnetic Resonance ImagingPatients with retroperitoneal sarcoma randomised into surgery alone arm. |
| Pre-operative radiotherapy plus surgery | – | Procedure: Magnetic Resonance ImagingPatients with retroperitoneal sarcoma randomised to Arm 2: pre-operative radiotherapy plus surgery. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with retroperitoneal sarcoma randomised for preoperative radiotherapy plus surgery versus surgery alone.
Key inclusion criteria (1 listed)
- Patients with retroperitoneal sarcomas planned for surgical resection +/- preoperative radiotherapy.
Key exclusion criteria (2 listed)
- MRI incompatible metal implants
- claustrophobia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance Imaging | Procedure or surgery | Curative intent surgery alone, Pre-operative radiotherapy plus surgery |
Primary outcome
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.
1 secondary outcome
To determine the reproducibility of multi-parametric MRI measurements within tumour regions of interest in patients with retroperitoneal sarcoma.
Time frame: 1-7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2018.
- Derived from this study: PubMed 31106141Winfield 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Institute of Cancer Research, United Kingdom at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prediction, by MRI, of early response to radiotherapy prior to tumour shrinkage (time frame: 2-4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01902667, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2018; AzTrials last refreshed its copy on 28 Oct 2026.