Electrochemotherapy in Musculoskeletal Tumors

NCT07323017 | Active Not Recruiting

• 1 other identifier: ELECTRO
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The study involves the enrollment of patients over 2 years of age with a diagnosis of musculoskeletal tumors and an indication for electrochemotherapy, treated at the Rizzoli Orthopaedic Institute in Bologna and followed during outpatient follow-up. Data will be collected from medical records, outpatient reports, and imaging studies including CT, X-ray, MRI, and/or PET. For the retrospective part of the study, patients treated at the Rizzoli Orthopaedic Institute from 01/01/2024 to the date of approval of this study will be included. For the prospective part, patients meeting the inclusion criteria and treated from the study start date until 31/12/2030 will be enrolled.

Conditions

Bone Tumors

Outcome Measures

Primary Outcomes (1)

• Tumor size will be assessed using CT, MRI, X-ray, and/or PET imaging. Tumor size will be defined as the longest diameter of the target lesion (mm).

  3, 6, and 12 months after electrochemotherapy

Secondary Outcomes (1)

• Change from baseline in pain intensity measured by the Visual Analog Scale (VAS), ranging from 0 to 10, where higher scores indicate worse pain, at 3, 6, and 12 months after electrochemotherapy.Number of participants with treatment-related adverse events

  3, 6, and 12 months after treatment

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will include patients older than 2 years with a diagnosis of musculoskeletal tumors who are indicated for electrochemotherapy, treated at the Rizzoli Orthopaedic Institute in Bologna and followed during outpatient follow-up. Data will be collected from medical records, outpatient reports, and imaging studies (CT, X-ray, MRI, and/or PET). The retrospective part will include patients treated at the Rizzoli Orthopaedic Institute from January 1, 2024, to the date of study approval. The prospective part will enroll patients meeting the inclusion criteria who will be treated from the study start date until December 31, 2030.

You may qualify if:

• Patients of both sexes with a histological diagnosis of a primary musculoskeletal tumor, either benign or malignant, located outside the abdominal cavity (trunk and limbs)
• Indication for electrochemotherapy due to one of the following conditions:
• Clinical conditions contraindicating surgery
• Tumor not surgically resectable
• Patients treated with electrochemotherapy at the Rizzoli Orthopaedic Institute:
• From 01/01/2024 to the date of study approval for the retrospective phase
• From the date of study approval to 12/31/2030 for the prospective phase
• Retrospectively treated patients with a minimum follow-up of at least 3 months
• Age ≥ 2 years at the time of treatment
• Availability of clinical and instrumental data

Sponsors & Collaborators

• Costantino Errani: lead

Study Sites (1)

Irccs Istituto Ortopedico Rizzoli

Bologna, Emilia-Romagna, 40134, Italy

Location

Related Publications (2)

• Campanacci L, Cevolani L, De Terlizzi F, Saenz L, Ali N, Bianchi G, Donati DM. Electrochemotherapy Is Effective in the Treatment of Bone Metastases. Curr Oncol. 2022 Mar 4;29(3):1672-1682. doi: 10.3390/curroncol29030139.

  PMID: 35323339 RESULT

• Cevolani L, Campanacci L, Staals EL, Dozza B, Bianchi G, De Terlizzi F, Donati DM. Is the association of electrochemotherapy and bone fixation rational in patients with bone metastasis? J Surg Oncol. 2023 Jul;128(1):125-133. doi: 10.1002/jso.27247. Epub 2023 Mar 26.

  PMID: 36966436 RESULT

MeSH Terms

Conditions

Bone Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Bone Diseases; Musculoskeletal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: January 7, 2026
• Study Start: August 1, 2025
• Primary Completion (Estimated): December 30, 2030
• Study Completion (Estimated): June 30, 2032
• Last Updated: January 14, 2026

Record last verified: 2026-01

Locations

IT (1)