- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06224283
Radiomics Compared With Conventional Response Criteria for Predicting Progression of Desmoid Tumor After Cryoablation (Cryomics)
Confronto Tra Radiomica e i Criteri Convenzionali di Risposta Nella Previsione Della Progressione Del Tumore Desmoide Dopo Crioablazione
Study Overview
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Bologna, Italy, 40136
- Recruiting
- Giancarlo Facchini
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Contact:
- Giancarlo Facchini
- Phone Number: 3336500944
- Email: giancarlo.facchini@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Performed cryotherapy
Patients who received cryoablation for desmoid tumor and no chemotherapy
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression of disease using mRECIST 1.1 criteria
Time Frame: 6 months
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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. |
6 months
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Auloge P, Garnon J, Robinson JM, Thenint MA, Koch G, Caudrelier J, Weiss J, Cazzato RL, Kurtz JE, Gangi A. Percutaneous cryoablation for advanced and refractory extra-abdominal desmoid tumors. Int J Clin Oncol. 2021 Jun;26(6):1147-1158. doi: 10.1007/s10147-021-01887-y. Epub 2021 Mar 11.
- Limkin EJ, Sun R, Dercle L, Zacharaki EI, Robert C, Reuze S, Schernberg A, Paragios N, Deutsch E, Ferte C. Promises and challenges for the implementation of computational medical imaging (radiomics) in oncology. Ann Oncol. 2017 Jun 1;28(6):1191-1206. doi: 10.1093/annonc/mdx034.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CE AVEC: 570/2023/Oss/IOR
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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