Electrochemotherapy in Musculoskeletal Tumors

Electrochemotherapy in Musculoskeletal Tumors: A Quantitative Assessment of Tumor Size Variations and Treatment-related Pain Reduction.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07323017

Enrollment

Registered

2026-01-07

Start date

2025-08-01

Completion date

2032-06-30

Last updated

2026-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Tumors

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

2 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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: 1. Clinical conditions contraindicating surgery 2. Tumor not surgically resectable * Patients treated with electrochemotherapy at the Rizzoli Orthopaedic Institute: 1. From 01/01/2024 to the date of study approval for the retrospective phase 2. 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

Exclusion criteria

• Failure to meet at least one of the inclusion criteria

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Italy

Outcome results