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Multiparametric Quantitative MRI and Response to Neoadjuvant Radiotherapy for Soft-tissue Sarcoma

NCT05684874 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2023-10-30

No results posted yet for this study

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).

Conditions

  • Soft Tissue Sarcoma
  • Adult Soft Tissue Sarcoma
  • Resectable Soft Tissue Sarcoma

Interventions

RADIATION

Neoadjuvant RT

Dosimetric CT scan with contrast injection for treatment planning. Radiation therapy at a dose of 50Gy in 25 fractions, 5 fractions per week. Daily pre-treatment positioning tomographic imaging (either high energy (MVCT) or cone beam computed tomography (CBCT)). Delineation of the tumor volume and evaluation of its evolution. In case of change of volume and if medically relevant, new dosimetric scan and collection of the tumor volume.

OTHER

Pre-radiotherapy mpMRI

Performed less than 14 days before the dosimetric scan. Conventional morphological T1-weighted, T2-weighted, and T1-weighted imaging sequences after injection of contrast agent. Quantitative imaging sequences including multiple b-value diffusion imaging. Chemical shift sensitized sequences.

OTHER

Post-radiotherapy mpMRI

Performed 4 to 6 weeks after the end of the radiotherapy. Conventional morphological T1-weighted, T2-weighted, and T1-weighted imaging sequences after injection of contrast agent. Quantitative imaging sequences including multiple b-value diffusion imaging. Chemical shift sensitized sequences.

PROCEDURE

Tumor resection

Performed 6 to 8 weeks after the end of radiotherapy. An anatomopathological observation of the surgical specimen will be performed.

Sponsors & Collaborators

  • Centre Leon Berard

    lead OTHER

Principal Investigators

  • Benoît ALLIGNET, MD · Centre Leon Berard

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-21
Primary Completion
2023-07-05
Completion
2024-01-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05684874 on ClinicalTrials.gov