Soft Tissue Sarcoma Clinical Trial
— SarQuantIRMOfficial title:
Neoadjuvant Radiotherapy of Soft Tissue Sarcomas of Limbs and Trunk : Interest of Multiparametric Quantitative MRI for Response Assessment and Per-treatment Progression Prediction
NCT number | NCT05684874 |
Other study ID # | ET22-301 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 21, 2023 |
Est. completion date | January 2024 |
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).
Status | Recruiting |
Enrollment | 25 |
Est. completion date | January 2024 |
Est. primary completion date | July 5, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
France | Centre Léon Bérard | Lyon | Rhône |
Lead Sponsor | Collaborator |
---|---|
Centre Leon Berard |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Predictive biomarkers of risk factors for tumor progression in pre-radiotherapy mpMRI | ROC curves will be generated to evaluate the performance of remnographic parameters for the prediction of per-treatment progression using the area under the ROC curve (AUC). | Pre-radiotherapy mpMRI performed within 14 days before the dosimetric scan. 5 weeks of daily image guided radiotherapy. | |
Other | Remnographic data and anatomopathological specimen results | Qualitative geographic correlation between post-radiotherapy remnographic data and pathological observation of necrosis, fibrosis and perennial cell areas. | 4 to 6 weeks after radiation therapy completion (remnographic data), and 6 to 8 weeks after radiation therapy completion (anatomopathological specimen results). | |
Primary | Maximum axial dimension | Evolution of the maximum axial dimension (mm) after neoadjuvant radiotherapy, obtained with quantitative multiparametric MRI | Pre-radiotherapy mpMRI performed within 14 days before the dosimetric scan. Post-radiotherapy mpMRI performed 4 to 6 weeks after radiation therapy completion. | |
Primary | Volume of the region of interest (ROI) | Evolution of the volume of the region of interest (ROI) (mm3) after neoadjuvant radiotherapy, obtained with quantitative multiparametric MRI | Pre-radiotherapy mpMRI performed within 14 days before the dosimetric scan. Post-radiotherapy mpMRI performed 4 to 6 weeks after radiation therapy completion. | |
Primary | Minimum, maximum, mean, median, 10th, 25th, 75th and 90th percentile values of free diffusion (D) and microperfusion-related diffusion (D*). | 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 | Pre-radiotherapy mpMRI performed within 14 days before the dosimetric scan. Post-radiotherapy mpMRI performed 4 to 6 weeks after radiation therapy completion. | |
Primary | Fraction of perfusion (f) | Evolution of the fraction of perfusion (f) after neoadjuvant radiotherapy, obtained with quantitative multiparametric MRI | Pre-radiotherapy mpMRI performed within 14 days before the dosimetric scan. Post-radiotherapy mpMRI performed 4 to 6 weeks after radiation therapy completion. | |
Secondary | Predictive biomarker of complete pathological response in pre-radiotherapy mpMRI | ROC curves will be generated to evaluate the performance of remnographic parameters for the prediction of complete pathological response using the area under the ROC curve (AUC). | Pre-radiotherapy mpMRI performed within 14 days before the dosimetric scan. Surgery performed 6 to 8 weeks after radiation therapy completion. |
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