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Bone LesionNCT05738941

Interventional Radiology in Bony Lesions

An observational study of Bone Lesion, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To explore the capability of the interventional radiology techniques in management of the painful bony lesions . Read more about this study

Who is it for?
Any age
Conditions the study is for
Bone Lesion
What is being tested?
radiofrequency ablation and angioembolization
How many people
50 participants
Where
No sites listed yet
Study dates
1 Mar 2025to 30 Apr 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

  • Painful primary bone tumors .
  • Bone secondaries not amenable to radiation therapy .
  • histopathologically radioresistant bony tumors.
  • Painful osteoporotic vertebral fractures.

Who cannot join

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

Trial locations and contacts

No sites are listed yet.

Mostafa Othman, PHD contact

01000684012

hashemradiol@aun.edu.eg

Momtaz Mohamed, MD contact

01062013112

Momtaz_Allam@Aun.Edu.Eg

About this study

Official title: 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 .

Read the 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].

Conditions
Bone Lesion
Being tested
radiofrequency ablation, angioembolization

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • radiofrequency ablationProcedure or surgery

    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

  • angioembolizationProcedure or surgery

    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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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 .

    Measured: 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 outcomes (2)

  1. 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.

    Measured: preoperatively and 1 month after the treatment to assess the effect of treatment on level of mobility and ability to walk

  2. Local tumor control

    the absence of viable tissue enhancing at imaging within the entire tumor treated

    Measured: performed 6 months after the treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2023
  2. Study start1 Mar 2025 (estimated)
  3. Primary completion31 Mar 2025 (estimated)
  4. Study completion30 Apr 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05738941
Sponsor's protocol ID
bone interventional radiology
Status last verified
Feb 2023
First submitted
13 Feb 2023
Last updated
28 Feb 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

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

    PubMed 21629401

  • 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.

    PubMed 35743336

  • 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.

    PubMed 28236103

  • 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.

    PubMed 22357881

  • 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.

    PubMed 19304917

  • 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.

    PubMed 36005203

  • 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.

    PubMed 34094020

  • 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.

    PubMed 36443787

Questions about this trial

What is this clinical trial studying?

An observational study of Bone Lesion, run by Assiut University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mostafa Othman, PHD (01000684012, hashemradiol@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05738941, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2023.

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