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RecruitingNCT06224283

Radiomics Compared With Conventional Response Criteria for Predicting Progression of Desmoid Tumor After Cryoablation

Confronto Tra Radiomica e i Criteri Convenzionali di Risposta Nella Previsione Della Progressione Del Tumore Desmoide Dopo Crioablazione

Status
Recruiting
Phase
Study type
Observational
Enrollment
21 (estimated)
Sponsor
Istituto Ortopedico Rizzoli · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

Summary

Desmoid tumors (DT) are uncommon tumors that arise from musculoaponeurotic structures. Despite benign, they can cause pain and disability due to their tendency to be locally aggressive. Cryoablation, a technique used in interventional radiology, has gained popularity in recent years as a treatment option for sporadic DT. This involves repeated cycles of freezing, leading to cell death. Recent studies showed that percutaneous image-guided cryoablation appears to be safe and effective for local control for patients with extra-abdominal desmoid tumors.Although changes in the heterogeneity of tumors are commonly known, they are often ignored in response criteria that only evaluate tumor size in a single dimension, such as Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Nevertheless, MRI can reveal early changes in tumor heterogeneity in responding tumors, resulting from a reduction in cellular area and an increase in fibro-necrotic content, before any dimensional changes occur. These changes in heterogeneity can be quantified using a radiomics approach. The aim of this study is to develop radiomics response criteria dedicated to the evaluation of DT treated with cryoablation as a first line treatment and to compare their performance with those of alternative radiologic response criteria for predicting progression according to RECIST 1.1.

Conditions

Interventions

TypeNameDescription
PROCEDURECryoablationCryoablation, a technique used in interventional radiology, involves repeated cycles of freezing, leading to cell death. Recent studies showed that percutaneous image-guided cryoablation appears to be safe and effective for local control for patients with extra-abdominal desmoid tumors

Timeline

Start date
2024-02-20
Primary completion
2026-10-31
Completion
2026-10-31
First posted
2024-01-25
Last updated
2025-01-24

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT06224283. Inclusion in this directory is not an endorsement.