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Active, Not Recruiting

NCT Number: NCT07323017

Electrochemotherapy in Musculoskeletal Tumors

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Bone Tumors Bone Diseases Bone Neoplasms Musculoskeletal Diseases Neoplasms Neoplasms by Site

Age range

2 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Irccs Istituto Ortopedico Rizzoli

Bologna, Emilia-Romagna, 40134, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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

Exclusion criteria

  • Failure to meet at least one of the inclusion criteria

Treatment and study plan

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).

    Time frame: 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

    Time frame: 3, 6, and 12 months after treatment

Sponsors and collaborators

Lead sponsor

Costantino Errani

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2030
Study completion
2032
First posted
Jan 7, 2026
Registry last updated
Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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