Back to results

MRI in Pre-operative Radiotherapy for Soft Tissue Sarcoma: MISTS Study

Primary Purpose

Sarcoma

Status

Completed

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

MRI scanning

About this trial

This is an interventional basic science trial for Sarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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
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

Exclusion Criteria:

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
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

Sites / Locations

The Christie NHS Foundation Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MRI scanning

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)

accuracy of outlining treatment volumes using STIR. T1W, T2W and DWI MRI compared to standard planning CT and loco-regional control patterns

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

Full Information

NCT ID

NCT01956019

First Posted

April 26, 2013

Last Updated

April 25, 2017

Sponsor

The Christie NHS Foundation Trust

1. Study Identification

Unique Protocol Identification Number

NCT01956019

Brief Title

MRI in Pre-operative Radiotherapy for Soft Tissue Sarcoma: MISTS 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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Completed

Study Start Date

February 2014 (Actual)

Primary Completion Date

January 2017 (Actual)

Study Completion Date

January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The Christie NHS Foundation Trust

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sarcoma

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MRI scanning

Arm Type

Experimental

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

MRI scanning

Primary Outcome Measure Information:

Title

Correlate histological response of soft tissue sarcoma after pre-operative radiotherapy with pre-treatment DWI and DCE-MRI parameters.

Description

Time Frame

average of 9 weeks including radiotherapy up to one week before surgery

Secondary Outcome Measure Information:

Title

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

Title

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

Title

local recurrence patterns with pre-treatment functional MRI.

Description

Time Frame

3 timepoints for scans over 6 weeks of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 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 Exclusion Criteria: 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Prakash Manoharan

Organizational Affiliation

The Christie NHS Foundation Trust

Official's Role

Study Chair

Facility Information:

Facility Name

The Christie NHS Foundation Trust

City

Manchester

ZIP/Postal Code

M20 4BX

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

MRI in Pre-operative Radiotherapy for Soft Tissue Sarcoma: MISTS Study

We'll reach out to this number within 24 hrs