Interventional Radiology in Bony Lesions

NCT ID: NCT05738941

Last Updated: 2023-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-01

Study Completion Date

2025-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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\[1\].

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bone Lesion

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type 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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 .
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Kero Wagdy

principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ehab Mousa, MD

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Mostafa Othman, PHD

Role: CONTACT

01000684012

Momtaz Mohamed, MD

Role: CONTACT

01062013112

References

Explore related publications, articles, or registry entries linked to this study.

Owen RJ. Embolization of musculoskeletal bone tumors. Semin Intervent Radiol. 2010 Jun;27(2):111-23. doi: 10.1055/s-0030-1253510.

Reference Type BACKGROUND
PMID: 21629401 (View on PubMed)

Sgalambro F, Zugaro L, Bruno F, Palumbo P, Salducca N, Zoccali C, Barile A, Masciocchi C, Arrigoni F. Interventional Radiology in the Management of Metastases and Bone Tumors. J Clin Med. 2022 Jun 7;11(12):3265. doi: 10.3390/jcm11123265.

Reference Type BACKGROUND
PMID: 35743336 (View on PubMed)

Barile A, Arrigoni F, Zugaro L, Zappia M, Cazzato RL, Garnon J, Ramamurthy N, Brunese L, Gangi A, Masciocchi C. Minimally invasive treatments of painful bone lesions: state of the art. Med Oncol. 2017 Apr;34(4):53. doi: 10.1007/s12032-017-0909-2. Epub 2017 Feb 24.

Reference Type BACKGROUND
PMID: 28236103 (View on PubMed)

Rosenthal D, Callstrom MR. Critical review and state of the art in interventional oncology: benign and metastatic disease involving bone. Radiology. 2012 Mar;262(3):765-80. doi: 10.1148/radiol.11101384.

Reference Type BACKGROUND
PMID: 22357881 (View on PubMed)

Rybak LD, Rosenthal DI, Wittig JC. Chondroblastoma: radiofrequency ablation--alternative to surgical resection in selected cases. Radiology. 2009 May;251(2):599-604. doi: 10.1148/radiol.2512080500. Epub 2009 Mar 20.

Reference Type BACKGROUND
PMID: 19304917 (View on PubMed)

Pusceddu C, De Francesco D, Ballicu N, Santucci D, Marsico S, Venturini M, Fior D, Moramarco LP, Faiella E. Safety and Feasibility of Steerable Radiofrequency Ablation in Combination with Cementoplasty for the Treatment of Large Extraspinal Bone Metastases. Curr Oncol. 2022 Aug 20;29(8):5891-5900. doi: 10.3390/curroncol29080465.

Reference Type BACKGROUND
PMID: 36005203 (View on PubMed)

Koo JS, Chung SH. The Efficacy of Radiofrequency Ablation for Bone Tumors Unsuitable for Radical Excision. Clin Orthop Surg. 2021 Jun;13(2):278-285. doi: 10.4055/cios19179. Epub 2021 May 18.

Reference Type BACKGROUND
PMID: 34094020 (View on PubMed)

Wang B, Zhang K, Zhang X, Yang S, Hu M, Li P, Yang W, Fan J, Xing C, Yuan Q. Microwave ablation combined with cementoplasty under real-time temperature monitoring in the treatment of 82 patients with recurrent spinal metastases after radiotherapy. BMC Musculoskelet Disord. 2022 Nov 29;23(1):1025. doi: 10.1186/s12891-022-05999-y.

Reference Type BACKGROUND
PMID: 36443787 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

bone interventional radiology

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.