Ignite Creation Date:
2024-05-06 @ 8:01 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06224283
Status:
RECRUITING
Last Update Posted:
2024-03-20
First Post:
2024-01-16
Brief Title:
Radiomics Compared With Conventional Response Criteria for Predicting Progression of Desmoid Tumor After Cryoablation
Sponsor:
Istituto Ortopedico Rizzoli
Organization:
Istituto Ortopedico Rizzoli
Study Overview
Official Title:
Confronto Tra Radiomica e i Criteri Convenzionali di Risposta Nella Previsione Della Progressione Del Tumore Desmoide Dopo Crioablazione
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Cryomics
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 tumorsAlthough 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 11 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 11
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None