Actively Recruiting

All Genders
NCT06224283

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

Led by Istituto Ortopedico Rizzoli · Updated on 2026-05-12

21

Participants Needed

1

Research Sites

140 weeks

Total Duration

On this page

Sponsors

I

Istituto Ortopedico Rizzoli

Lead Sponsor

U

University of Sao Paulo

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Desmoid tumor treated at Rizzoli Orthopaedic Institute with cryoablation
  • Baseline MRI
  • Clinical and radiologic follow-up every 3 months until disease progression or new treatment, with at least 6 months follow-up
Not Eligible

You will not qualify if you...

  • Not meeting the inclusion criteria

AI-Screening

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Trial Site Locations

Total: 1 location

1

Giancarlo Facchini

Bologna, Italy, 40136

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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