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

May 22, 2023 updated by: Alberto Bazzocchi, Istituto Ortopedico Rizzoli

Diagnostic Yield of Ultrasound-Guided Needle Biopsy in the Diagnosis of Musculoskeletal Soft-Tissue Tumors

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Bo
      • Bologna, Bo, Italy, 40136
        • The Rizzoli Orthopaedic Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study will enroll 350 patients who underwent US-CNB for soft tissue lesion at the Rizzoli Orthopaedic Institute

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic yield
Time Frame: 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.
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prediction of malignancy
Time Frame: One year
To determine which imaging features and biomarkers correlates with malignancy and biological behavior of soft tissue masses.
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Ortopedico Rizzoli

Investigators

  • Principal Investigator: Alberto Bazzocchi, MD, PhD, The Rizzoli Ortopaedic Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2018

Primary Completion (Actual)

January 15, 2019

Study Completion (Actual)

September 20, 2020

Study Registration Dates

First Submitted

February 23, 2018

First Submitted That Met QC Criteria

March 1, 2018

First Posted (Actual)

March 2, 2018

Study Record Updates

Last Update Posted (Actual)

May 23, 2023

Last Update Submitted That Met QC Criteria

May 22, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Softbiopsy@IOReco

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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