Interventional Radiology in Bony Lesions

Not yet recruiting

• Conditions: Bone Lesion

• Registration Number: NCT05738941
• Lead Sponsor: Assiut University

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\[1\].

Study Timeline

• Status Verified: 2023-02
• Study First Submitted: 2023-02-13
• Study First Submitted QC: 2023-02-13
• Study First Posted: 2023-02-22
• Last Update Submitted: 2023-02-25
• Last Update Posted: 2023-02-28
• Study Start: 2025-03-01
• Primary Completion: 2025-03-31
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
pain management	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 .

Secondary Outcome Measures

Name	Time	Method
The Functional Mobility Scale (FMS)	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.
Local tumor control	performed 6 months after the treatment	the absence of viable tissue enhancing at imaging within the entire tumor treated