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

NCT05684874 | Unknown

• 1 other identifier: ET22-301
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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).

Conditions

Soft Tissue Sarcoma; Adult Soft Tissue Sarcoma; Resectable Soft Tissue Sarcoma

Keywords

Oncology; Soft Tissue Sarcoma; Multiparametric quantitative MRI; Neoadjuvant radiotherapy; Limbs and trunk; Remnographic characteristics; Tumor resection; Anatomopathological response; Predictive biomarkers; Complete pathological response; Change in tumor volume; Adults; Resectable

Outcome Measures

Primary Outcomes (4)

• 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.

• 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.

• 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.

• 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 Outcomes (1)

• 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.

Other Outcomes (2)

• Predictive biomarkers of risk factors for tumor progression in pre-radiotherapy mpMRI

  Pre-radiotherapy mpMRI performed within 14 days before the dosimetric scan. 5 weeks of daily image guided radiotherapy.

• Remnographic data and anatomopathological specimen results

  4 to 6 weeks after radiation therapy completion (remnographic data), and 6 to 8 weeks after radiation therapy completion (anatomopathological specimen results).

Study Arms (1)

Pre- and post- radiotherapy multiparametric quantitative MRI

EXPERIMENTAL

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.

Radiation: Neoadjuvant RT; Other: Pre-radiotherapy mpMRI; Other: Post-radiotherapy mpMRI; Procedure: Tumor resection

Interventions

Neoadjuvant RT RADIATION

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.

Pre- and post- radiotherapy multiparametric quantitative MRI

Pre-radiotherapy mpMRI OTHER

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.

Pre- and post- radiotherapy multiparametric quantitative MRI

Post-radiotherapy mpMRI OTHER

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.

Pre- and post- radiotherapy multiparametric quantitative MRI

Tumor resection PROCEDURE

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

Pre- and post- radiotherapy multiparametric quantitative MRI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Leon Berard: lead

Study Sites (1)

Centre Léon Bérard

Lyon, Rhône, 69373, France

RECRUITING

MeSH Terms

Conditions

Sarcoma; Neoplasms; Pathologic Complete Response

Interventions

Transurethral Resection of Bladder

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Disease Progression; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Benoît ALLIGNET, MD

  Centre Leon Berard

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Benoît ALLIGNET, MD

CONTACT

+33 4 78 78 59 06; benoit.allignet@lyon.unicancer.fr

Benjamin LEPORQ, MD, PhD

CONTACT

+33 4 69 85 62 58; benjamin.leporq@creatis.insa-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2022
• First Posted: January 13, 2023
• Study Start: April 21, 2023
• Primary Completion: July 5, 2023
• Study Completion: January 1, 2024
• Last Updated: October 30, 2023

Record last verified: 2023-10

Locations

FR (1)