Interventional Radiology in Bony Lesions

NCT05738941 | Unknown

• 1 other identifier: bone interventional radiology
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Bone Lesion

Outcome Measures

Primary Outcomes (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 .

  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)

• 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

• Local tumor control

  performed 6 months after the treatment

Interventions

radiofrequency ablation PROCEDURE

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

angioembolization PROCEDURE

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (8)

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

  PMID: 21629401 BACKGROUND

• 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.

  PMID: 35743336 BACKGROUND

• 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.

  PMID: 28236103 BACKGROUND

• 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.

  PMID: 22357881 BACKGROUND

• 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.

  PMID: 19304917 BACKGROUND

• 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.

  PMID: 36005203 BACKGROUND

• 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.

  PMID: 34094020 BACKGROUND

• 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.

  PMID: 36443787 BACKGROUND

MeSH Terms

Interventions

Radiofrequency Ablation

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Ehab Mousa, MD

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mostafa Othman, PHD

CONTACT

01000684012; hashemradiol@aun.edu.eg

Momtaz Mohamed, MD

CONTACT

01062013112; Momtaz_Allam@Aun.Edu.Eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: February 22, 2023
• Study Start: March 1, 2025
• Primary Completion: March 31, 2025
• Study Completion: April 30, 2025
• Last Updated: February 28, 2023

Record last verified: 2023-02