US-Guided Biopsy in the Diagnosis of Musculoskeletal Soft-Tissue Tumors

Completed

• Conditions: Soft Tissue Neoplasm; Soft Tissue Lesion; Soft Tissue Sarcoma; Soft Tissue Mass

• Registration Number: NCT03452644
• Lead Sponsor: Istituto Ortopedico Rizzoli

Brief Summary

A retrospective evaluation of soft tissue tumors that have undergone core needle biopsy with US guidance (US-CNB)

Detailed Description

The present study is designed to be the first step in the creation of an interdisciplinary platform collecting data on patients and procedures to provide a predictive tool to help physicians in the management of patients affected by a soft tissue lesion.

The primary aim of our work is to evaluate the diagnostic yield of US-CNB. The secondary aim is to exploit all the imaging data conventionally available at a Sarcoma Center before a biopsy on a soft tissue mass, to build a multiparametric model and score of prediction of malignancy, and eventually of biological behavior - grading.

Study Timeline

• Study First Submitted: 2018-02-23
• Study First Submitted QC: 2018-03-01
• Study First Posted: 2018-03-02
• Study Start: 2018-09-20
• Primary Completion: 2019-01-15
• Study Completion: 2020-09-20
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-22
• Last Update Posted: 2023-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

• Patients undergone US-CNB for soft tissue lesions at the Rizzoli Orthopaedic Institute

Exclusion Criteria

• Patients whose histological diagnosis is not available

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic yield	One year	Diagnostic yield will be defined as the number of diagnostic core needle biopsies divided by the total number of core needle biopsies. A diagnostic yield \> 94% will be considered sufficient to produce a sample to reach the histological diagnosis.

Secondary Outcome Measures

Name	Time	Method
Prediction of malignancy	One year	To determine which imaging features and biomarkers correlates with malignancy and biological behavior of soft tissue masses.

Trial Locations

Locations (1)

The Rizzoli Orthopaedic Institute; 🇮🇹 Bologna, Bo, Italy