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NCT Number: NCT06224283

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

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Giancarlo Facchini

Bologna, 40136, Italy

Location status: Recruiting

Location contact

Giancarlo Facchini

CONTACT

[email protected]

3336500944

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • desmoid tumor treated at Rizzoli Orthopaedic Institute with cryoablation
  • baseline MRI
  • clinical and radiologic follow-up until disease progression or the start of a new line of treatment performed every 3 months, with a minimum of 6 months follow-up

Exclusion criteria

  • not meeting inclusion criteria

Treatment and study plan

Cryoablation

Procedure

Cryoablation, 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

Primary outcomes

  1. Progression of disease using mRECIST 1.1 criteria

    Time frame: 6 months

    The aim of this study is to develop radiomics response criteria dedicated to the evaluation of DT treated with cryoablation based on quantification of early changes in heterogeneity sign at MRI images and to compare their performance with those of alternative radiologic response criteria for predicting progression according to mRECIST 1.1.

    Description of mRECIST 1.1 criteria: CR = complete response, disappearing of contrast enhancement of all lesions; PR= partial response, ≥30% dicrease in the sum of the diameters of contrast enhancement of target lesions; SD= stable disease, neither partial response nor progressive disease; PD= progressive disease, ≥20% size increase in contrast enhancement of the target lesions or new disease.

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Collaborators

  • University of Sao Paulo

Registry information

Official study title

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

Acronym: Cryomics

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 25, 2024
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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