Interventional Radiology in Bony Lesions

February 25, 2023 updated by: Kero Wagdy, Assiut University

Interventional Radiology Strategies in Management of Painful Bony Lesions

To explore the capability of the interventional radiology techniques in management of the painful bony lesions .

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Bone tumors may present as incidental findings, with pain or loss of function, or as fractures [1].

Interventional Radiology (IR) has experienced an exponential growth in recent years. Technological advances of the last decades have made it possible to use new treatments on a larger scale, with good results in terms of safety and effectiveness[2] .

Today, IR represents a minimally invasive option of treatment for benign bony lesions (osteoid osteoma [OO], osteoblastoma, periosteal chondroma, etc.) and for palliation of metastases involving bone and soft-tissue sites beyond the liver and lung in an always-increasing number of cases [3][4].

The aim of minimally-invasive ablation treatment is addressing the biological pain due to the stretching and irritation of the periosteum secondary to tumor growth and due to osteoclast-mediated bone resorption with the release of neurostimulating cytokines. The purpose of cementoplasty is to treat the mechanical pain for the instability from pathologic microfractures [5] Radiofrequency ablation (RFA) and cementoplasty are safe, feasible, and promising clinical option for the management of painful bony tumors that are challenging for their morphology and location [6].

Also , there is a broad range of indications for transarterial embolization (TAE) in primary or metastatic bone tumors: to reduce operative haemorrhagic risks, to simplify or allow more definitive surgery, or in the context of pain palliation, fever, bleeding, or hypercalcemic and other rheological factors[1].

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

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

Study Contact

Study Contact Backup

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

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients coming to Assiut university hospitals with painful bony lesions fulfilling the inclusion criteria and need intervention

Description

Inclusion Criteria:

  1. Painful primary bone tumors .
  2. Bone secondaries not amenable to radiation therapy .
  3. histopathologically radioresistant bony tumors.
  4. Painful osteoporotic vertebral fractures.

Exclusion Criteria:

  • 1- Contraindications to contrast media 2- Raised renal chemistry or chronic kidney disease . 3- Pregnant patients . 4- Abnormal coagulation profile . 5- Contraindications to anesthesia .

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
pain management
Time Frame: visual analogue score will be evaluated before the procedure and at 1-week and 3-, 6-, and 12-month follow-up outpatient office visits

quantification of the pain before and after treatment through VAS ( visual analogue scale ) score .

it is a score from (0) to (10) . The minimum value (0) means no pain and highest value (10) means worst pain possible . Higher scores mean worse outcome .
visual analogue score will be evaluated before the procedure and at 1-week and 3-, 6-, and 12-month follow-up outpatient office visits

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Functional Mobility Scale (FMS)
Time Frame: preoperatively and 1 month after the treatment to assess the effect of treatment on level of mobility and ability to walk
assess the effect of treatment on level of mobility and ability to walk. A 4-point FMS classification is used: 4, bedridden; 3, use of wheelchair; 2, limited painful ambulation; 1, normal ambulation.
preoperatively and 1 month after the treatment to assess the effect of treatment on level of mobility and ability to walk
Local tumor control
Time Frame: performed 6 months after the treatment
the absence of viable tissue enhancing at imaging within the entire tumor treated
performed 6 months after the treatment

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Principal Investigator: Ehab Mousa, MD, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

March 1, 2025

Primary Completion (Anticipated)

March 31, 2025

Study Completion (Anticipated)

April 30, 2025

Study Registration Dates

First Submitted

February 13, 2023

First Submitted That Met QC Criteria

February 13, 2023

First Posted (Actual)

February 22, 2023

Study Record Updates

Last Update Posted (Estimate)

February 28, 2023

Last Update Submitted That Met QC Criteria

February 25, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • bone interventional radiology

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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