Clinical trial NCT06224283: Radiomics Compared With Conventional Response Criteria for Predicting Progression of Desmoid Tumor After Cryoablation
Official title: Confronto Tra Radiomica e i Criteri Convenzionali di Risposta Nella Previsione Della Progressione Del Tumore Desmoide Dopo Crioablazione
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Desmoid
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
Collaborators: name: University of Sao Paulo
First posted: 2024-01-25
Enrollment: 21
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who were treated with cryoablation for desmoid tumor

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Progression of disease using mRECIST 1.1 criteria
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Giancarlo Facchini
Study officials:
References:
citation: 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.
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.