SarcomaNCT01956019
MRI in Pre-operative Radiotherapy for Soft Tissue Sarcoma: MISTS Study
A study testing MRI scanning in people with Sarcoma, run by The Christie NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This study will use diffusion weighted MRI (DWI MRI) and dynamic-contrast enhanced MRI (DCE MRI) techniques to detect changes in sarcoma tumour vasculature. The main aims of this study are to correlate histological response of soft tissue sarcoma after pre-operative radiotherapy with several pre-treatment DCE and DWI… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma
- What is being tested?
- MRI scanning
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2014to Jan 2017
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have histologically confirmed diagnosis of intermediate/high grade soft tissue sarcoma (STS)
- Patients must be suitable for treatment with preoperative radiotherapy and radical surgery
- Standard radiological assessments (CT or MRI) may have already been performed but must be done within 4 weeks of starting radiotherapy
- Patient must have measurable disease on CT/MRI imaging
- ECOG performance status 0-2
- Adequate pre-treatment haematological and biochemical parameters
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- Age greater than or equal to 18 years
- No significant co-morbidity thereby excluding patient from having radical treatment.
- No previous treatment for diagnosis of STS including neo-adjuvant chemotherapy
- Women of child bearing age MUST have a negative pregnancy test prior to study entry and be using an adequate contraception method unless child bearing potential has been terminated by surgery/radical radiotherapy
- Patients must have given written informed consent
Who cannot join
- Patients with cardiac pacemakers, cochlear implants, intraocular foreign bodies or any other MRI incompatibility factors (e.g. recent surgery).
- Patients with a known history of anaphylactic reaction to contrast material for MRI
- Previous administration of gadoxetic acid or other contrast material 24hr prior to or after the MRI
- Any evidence of severe or uncontrolled systemic diseases which, in the view of the investigator, makes it undesirable for the patient to participate in the trial
- Evidence of significant clinical disorder or laboratory finding which, in the opinion of the investigator makes it undesirable for the patient to participate in the trial
- Any other serious uncontrolled medical conditions
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- Clinical evidence of metastatic disease
- Any pregnant or lactating woman
- Any patient with a medical or psychiatric condition that impairs their ability to give informed consent
- Evidence of impaired renal function, serum creatinine >1.5x upper limit of normal
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Christie NHS Foundation Trust
Manchester, M20 4BX
About this study
Official title: Feasibility Study to Compare Early Response Assessment and Planning Volumes With Contrast-enhanced Computed Tomography (CT), MRI Including Diffusion Weighted MRI (DWI) and Dynamic-contrast Enhanced (DCE) MRI in Patients With Limb Sarcoma Undergoing Pre-operative Radiotherapy
This study will use diffusion weighted MRI (DWI MRI) and dynamic-contrast enhanced MRI (DCE MRI) techniques to detect changes in sarcoma tumour vasculature. The main aims of this study are to correlate histological response of soft tissue sarcoma after pre-operative radiotherapy with several pre-treatment DCE and DWI MRI parameters and to assess the impact of these on early response prediction. Detected changes may reflect the sensitivity of the tumour to radiotherapy and may be associated with long term outcomes after treatment.
15 patients normally having pre-operative radiotherapy as part of their sarcoma treatment will be recruited to this study.
Read more
Patients will have an additional three specialised MRI scans: one prior to the start of radiotherapy, one during the second week of radiotherapy while on treatment and one scan a week before surgery but after the completion of radiotherapy.
Post-operatively, results of the histological examination of the sarcoma will be correlated to both the MRI scan data and outcomes after treatment
- Conditions
- Sarcoma
- Being tested
- MRI scanning
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI scanningDevice
| Study group | Role | What they receive |
|---|---|---|
| MRI scanning | Experimental | patients undergo special MRI techniques (DWI-MRI and DCE-MRI) after their routine MRI examinations while undergoing routine radiotherapy. 3 lots of scans in total. They will also have a blood test. Receives: Device: MRI scanning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlate histological response of soft tissue sarcoma after pre-operative radiotherapy with pre-treatment DWI and DCE-MRI parameters.
The hypothesis is that quantitative biomarkers from DWI and DCE MRI can not only be produced with high spatial resolution in soft tissue sarcoma, but that these imaging biomarkers will correlate with histological and histochemical features of the tumour and will provide information to support the prediction of regional response to radiotherapy.
Measured: average of 9 weeks including radiotherapy up to one week before surgery
Secondary outcomes (3)
early response prediction of treatment using functional parameters of in-treatment imaging with DWI and DCE-MRI (e.g. relative change in apparent diffusion coefficient values)
Measured: following surgery at week 7
accuracy of outlining treatment volumes using STIR. T1W, T2W and DWI MRI compared to standard planning CT and loco-regional control patterns
Measured: 3 month follow up visit
local recurrence patterns with pre-treatment functional MRI.
Within our study, these patients would have an additional three specialised MRI scans: one prior to the start of radiotherapy, one during the second week of radiotherapy while on treatment and one scan the week before the operation after the completion of radiotherapy
Measured: 3 timepoints for scans over 6 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startFeb 2014
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Christie NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emmie Taylor, The Christie NHS Foundation Trust
- Investigators
- Prakash Manoharan, Study chair, The Christie NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01956019
- Sponsor's protocol ID
- 10_RADIO_96
- Status last verified
- Apr 2017
- First submitted
- 26 Apr 2013
- Last updated
- 26 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study to Compare Early Response Assessment and Planning Volumes With Contrast-enhanced Computed Tomography (CT), MRI Including Diffusion Weighted MRI (DWI) and Dynamic-contrast Enhanced (DCE) MRI in Patients With Limb Sarcoma Undergoing Pre-operative Radiotherapy
- ClinicalTrials.gov ID
- NCT01956019
- Acronym / sponsor ID
- 10_RADIO_96
- Conditions
- Sarcoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- The Christie NHS Foundation TrustUniversity, hospital or other
- Study start
- Feb 2014 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 8 Oct 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 study will use diffusion weighted MRI (DWI MRI) and dynamic-contrast enhanced MRI (DCE MRI) techniques to detect changes in sarcoma tumour vasculature. The main aims of this study are to correlate histological response of soft tissue sarcoma after pre-operative radiotherapy with several pre-treatment DCE and DWI MRI parameters and to assess the impact of these on early response prediction. Detected changes may reflect the sensitivity of the tumour to radiotherapy and may be associated with long term outcomes after treatment.
15 patients normally having pre-operative radiotherapy as part of their sarcoma treatment will be recruited to this study.
Patients will have an additional three specialised MRI scans: one prior to the start of radiotherapy, one during the second week of radiotherapy while on treatment and one scan a week before surgery but after the completion of radiotherapy.
Post-operatively, results of the histological examination of the sarcoma will be correlated to both the MRI scan data and outcomes after treatment
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI scanning | Experimental | Device: MRI scanningpatients undergo special MRI techniques (DWI-MRI and DCE-MRI) after their routine MRI examinations while undergoing routine radiotherapy. 3 lots of scans in total. They will also have a blood test. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients must have histologically confirmed diagnosis of intermediate/high grade soft tissue sarcoma (STS)
- Patients must be suitable for treatment with preoperative radiotherapy and radical surgery
- Standard radiological assessments (CT or MRI) may have already been performed but must be done within 4 weeks of starting radiotherapy
- Patient must have measurable disease on CT/MRI imaging
- ECOG performance status 0-2
Key exclusion criteria (10 listed)
- Patients with cardiac pacemakers, cochlear implants, intraocular foreign bodies or any other MRI incompatibility factors (e.g. recent surgery).
- Patients with a known history of anaphylactic reaction to contrast material for MRI
- Previous administration of gadoxetic acid or other contrast material 24hr prior to or after the MRI
- Any evidence of severe or uncontrolled systemic diseases which, in the view of the investigator, makes it undesirable for the patient to participate in the trial
- Evidence of significant clinical disorder or laboratory finding which, in the opinion of the investigator makes it undesirable for the patient to participate in the trial
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 |
|---|---|---|
| MRI scanning | Device | MRI scanning |
Primary outcome
Correlate histological response of soft tissue sarcoma after pre-operative radiotherapy with pre-treatment DWI and DCE-MRI parameters.
Time frame: average of 9 weeks including radiotherapy up to one week before surgery
The hypothesis is that quantitative biomarkers from DWI and DCE MRI can not only be produced with high spatial resolution in soft tissue sarcoma, but that these imaging biomarkers will correlate with histological and histochemical features of the tumour and will provide information to support the prediction of regional response to radiotherapy.
3 secondary outcomes
early response prediction of treatment using functional parameters of in-treatment imaging with DWI and DCE-MRI (e.g. relative change in apparent diffusion coefficient values)
Time frame: following surgery at week 7
accuracy of outlining treatment volumes using STIR. T1W, T2W and DWI MRI compared to standard planning CT and loco-regional control patterns
Time frame: 3 month follow up visit
local recurrence patterns with pre-treatment functional MRI.
Time frame: 3 timepoints for scans over 6 weeks of treatment
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 26 Apr 2017.
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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.
Prakash Manoharan study chair
The Christie NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI scanning in people with Sarcoma, run by The Christie NHS Foundation Trust 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 11 inclusion and 10 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 26 Apr 2017. 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?
Correlate histological response of soft tissue sarcoma after pre-operative radiotherapy with pre-treatment DWI and DCE-MRI parameters. (time frame: average of 9 weeks including radiotherapy up to one week before surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Apr 2017.