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

Desmoid Clinical Trial

— Cryomics  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06224283
• Other study ID #: CE AVEC: 570/2023/Oss/IOR
• Status: Recruiting
• Start date: February 20, 2024
• Est. completion date: December 1, 2024

Study information

• Verified date: March 2024
• Source: Istituto Ortopedico Rizzoli
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 21
• Est. completion date: December 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Desmoid

Intervention

Procedure:
• Cryoablation
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

Locations

Country	Name	City	State
Italy	Giancarlo Facchini	Bologna

Sponsors (2)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli	University of Sao Paulo

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression of disease using mRECIST 1.1 criteria	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