Neoadjuvant Radiotherapy of Soft Tissue Sarcomas of Limbs and Trunk : Interest of Multiparametric Quantitative MRI for Response Assessment and Per-treatment Progression Prediction
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Centre Leon Berard
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Maximum axial dimension
Study Overview
Brief Summary
This trial is a prospective, monocentric, with minimal risks and constraints study, conducted in patients with Soft Tissue Sarcoma (STS) of the limbs and trunk with indication for neoadjuvant radiotherapy (RT).
Patients will be treated by neoadjuvant RT and will have a pre-RT and a post-RT multiparametric quantitative Magnetic Resonance Imaging (MRI).
A tumor resection will be performed 6 to 8 weeks post-RT and an anatomopathological observation of the surgical specimen will be performed.
This study will allow to describe the initial remnographic characteristics and their evolution after neoadjuvant RT using quantitative multiparametric MRI (mpMRI).
Detailed Description
This study is prospective, monocentric and with minimal risks and constraints.
Patients with STS of the limbs and trunk will be accrued during the initial radiotherapy consultation radiotherapy (prior to receiving radiotherapy).
Two quantitative multiparametric MRI will be performed. The first one will be acquired less than 14 days before the dosimetric scan, the second one 4 to 6 weeks after the end of the radiotherapy.
This study will allow to describe the initial remnographic characteristics and their evolution after neoadjuvant RT using quantitative multiparametric MRI.
STATISTICAL ANALYSIS
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients 18 years of age or older;
- •Documented histologic diagnosis of soft tissue sarcoma of the limbs or trunk;
- •Validated indication for neoadjuvant radiotherapy, planned in the radiotherapy department of the Centre Léon Bérard;
- •No contraindication to Magnetic Resonance Imaging,
- •Signed informed consent;
- •Affiliation with a social security system or beneficiary of such a system.
Exclusion Criteria
- •Tumor considered as unresectable or patient considered as non-operable;
- •Desmoid tumor or dermatofibrosarcoma protuberans due to intermediate malignancy;
- •Rhabdomyosarcoma due to a different therapeutic management;
- •Multi-metastatic disease;
- •Pregnant or lactating woman,
- •Patient under guardianship, curatorship or deprived of liberty.
Arms & Interventions
Pre- and post- radiotherapy multiparametric quantitative MRI
Patients with STS of the limbs and trunk will be accrued during the initial radiotherapy consultation radiotherapy (prior to receiving radiotherapy).
Two quantitative multiparametric MRI will be performed. The first one will be acquired less than 14 days before the dosimetric scan, the second one 4 to 6 weeks after the end of the radiotherapy.
A tumor resection will be performed 6 to 8 weeks post-RT and an anatomopathological observation of the surgical specimen will be performed.
Intervention: Neoadjuvant RT (Radiation)
Pre- and post- radiotherapy multiparametric quantitative MRI
Patients with STS of the limbs and trunk will be accrued during the initial radiotherapy consultation radiotherapy (prior to receiving radiotherapy).
Two quantitative multiparametric MRI will be performed. The first one will be acquired less than 14 days before the dosimetric scan, the second one 4 to 6 weeks after the end of the radiotherapy.
A tumor resection will be performed 6 to 8 weeks post-RT and an anatomopathological observation of the surgical specimen will be performed.
Intervention: Pre-radiotherapy mpMRI (Other)
Pre- and post- radiotherapy multiparametric quantitative MRI
Patients with STS of the limbs and trunk will be accrued during the initial radiotherapy consultation radiotherapy (prior to receiving radiotherapy).
Two quantitative multiparametric MRI will be performed. The first one will be acquired less than 14 days before the dosimetric scan, the second one 4 to 6 weeks after the end of the radiotherapy.
A tumor resection will be performed 6 to 8 weeks post-RT and an anatomopathological observation of the surgical specimen will be performed.
Intervention: Post-radiotherapy mpMRI (Other)
Pre- and post- radiotherapy multiparametric quantitative MRI
Patients with STS of the limbs and trunk will be accrued during the initial radiotherapy consultation radiotherapy (prior to receiving radiotherapy).
Two quantitative multiparametric MRI will be performed. The first one will be acquired less than 14 days before the dosimetric scan, the second one 4 to 6 weeks after the end of the radiotherapy.
A tumor resection will be performed 6 to 8 weeks post-RT and an anatomopathological observation of the surgical specimen will be performed.
Intervention: Tumor resection (Procedure)
Outcomes
Primary Outcomes
Maximum axial dimension
Time Frame: Pre-radiotherapy mpMRI performed within 14 days before the dosimetric scan. Post-radiotherapy mpMRI performed 4 to 6 weeks after radiation therapy completion.
Evolution of the maximum axial dimension (mm) after neoadjuvant radiotherapy, obtained with quantitative multiparametric MRI
Volume of the region of interest (ROI)
Time Frame: Pre-radiotherapy mpMRI performed within 14 days before the dosimetric scan. Post-radiotherapy mpMRI performed 4 to 6 weeks after radiation therapy completion.
Evolution of the volume of the region of interest (ROI) (mm3) after neoadjuvant radiotherapy, obtained with quantitative multiparametric MRI
Minimum, maximum, mean, median, 10th, 25th, 75th and 90th percentile values of free diffusion (D) and microperfusion-related diffusion (D*).
Time Frame: Pre-radiotherapy mpMRI performed within 14 days before the dosimetric scan. Post-radiotherapy mpMRI performed 4 to 6 weeks after radiation therapy completion.
Evolution of the minimum, maximum, mean, median, 10th, 25th, 75th and 90th percentile values of free diffusion (D) and microperfusion-related diffusion (D\*) (mm2/s) after neoadjuvant radiotherapy, obtained with quantitative multiparametric MRI
Fraction of perfusion (f)
Time Frame: Pre-radiotherapy mpMRI performed within 14 days before the dosimetric scan. Post-radiotherapy mpMRI performed 4 to 6 weeks after radiation therapy completion.
Evolution of the fraction of perfusion (f) after neoadjuvant radiotherapy, obtained with quantitative multiparametric MRI
Secondary Outcomes
- Predictive biomarker of complete pathological response in pre-radiotherapy mpMRI(Pre-radiotherapy mpMRI performed within 14 days before the dosimetric scan. Surgery performed 6 to 8 weeks after radiation therapy completion.)