Interventional Radiology in Bony Lesions

Study Overview
=================
Brief Summary
-----------------
To explore the capability of the interventional radiology techniques in management of the painful bony lesions .

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].

Official Title
-----------------
Interventional Radiology Strategies in Management of Painful Bony Lesions

Conditions
-----------------
Bone Lesion

Intervention / Treatment
-----------------
* Procedure: radiofrequency ablation
* Procedure: angioembolization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Painful primary bone tumors . Bone secondaries not amenable to radiation therapy . histopathologically radioresistant bony tumors. 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 .
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: radiofrequency ablation|17-G length-adjustable electrode (RITA RF Electrode;) a 200-W RF generator is going to be used,under CT fluoroscopic guidance. The type of the electrode and the length of the active tip will be selected according to the size, location, and shape of the tumor, as well as the operator preference.ablation will be performed with 100 W energy for 30 seconds. The number of electrodes placed, ablation time per electrode, total ablation time, and total energy delivered to targets, as well as the temperature of the lesions, will be recorded. For lesions less than 3 cm, surgery was performed with one electrode , and for lesions of 3 cm or more, two or more electrodes were used . The procedure may be followed by injection of bone cement through the same working cannula, and a long working time will be delivered (STABILIT, Merit Medical Systems, Inc.) for the optimal filling of the bone lesion|
|Procedure: angioembolization|Use a 4- or 5-French diagnostic catheter for the initial angiogram and either continue to use this catheter for embolization where the feeding vessel is large or add a standard 2.3- to 2.5-French microcatheter as a coaxial technique . - Injection of embolizing material in the feeding vessels using gel foam , PVA or histoacryl according to the nature of the bony lesion|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain management | 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) | 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 | the absence of viable tissue enhancing at imaging within the entire tumor treated | performed 6 months after the treatment |