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ID06224283

Radiomics Compared With Conventional Response Criteria to Predict Progression of Desmoid Tumor After Cryoablation

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

21

Participants Needed

1

Research Sites

N/A

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 are rare growths that develop from musculoaponeurotic tissues. Although benign, they can cause pain and disability due to their local aggressiveness. Researchers are evaluating how a radiomics approach, which analyzes changes in tumor heterogeneity seen on MRI, compares to conventional methods like RECIST 1.1 in predicting tumor progression after cryoablation treatment for desmoid tumors. The study focuses on patients who have received cryoablation, a procedure that uses repeated cycles of freezing to destroy tumor cells, as their first line treatment for extra-abdominal desmoid tumors. Cryoablation is performed under image guidance and has been shown to be safe for local tumor control. Participants will have baseline MRI scans and clinical and radiologic follow-ups every three months for at least six months or until disease progression or starting new treatment. Participants will undergo regular MRI scans and clinical evaluations to monitor tumor changes and progression using both radiomics and conventional response criteria. The primary outcome is disease progression assessed by mRECIST 1.1 at six months. The study involves careful imaging and clinical follow-up to compare how well radiomics predicts progression compared to standard size-based criteria, with all evaluations performed over a minimum six-month period.

CONDITIONS

Brief 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 performed
  • Clinical and radiologic follow-up every 3 months until disease progression or new treatment start, with at least 6 months follow-up
Not Eligible

You will not qualify if you...

  • Not meeting inclusion criteria

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - 1 day

Participants undergo cryoablation, a procedure using repeated freezing cycles to treat desmoid tumors.

1 visit (in-person)

Long-term Monitoring

Duration - At least 6 months

Participants receive clinical and radiologic follow-up every 3 months to monitor disease progression or need for new treatment.

Follow-up visits every 3 months

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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Published Research Related To This Trial