Orthopedic Oncology Surgery: Navigation, Intraoperative Imaging and Virtual Reality

Sponsor

Regina Elena Cancer Institute (Other)

Overall Status

Recruiting

CT.gov ID

NCT05918536

Collaborator

Azienda Policlinico Umberto I (Other), Istituto Ortopedico Galeazzi (Other)

Enrollment

Location

42.1

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Noninterventional, prospective study of patients operated on for musculoskeletal neoplasms designed to evaluate the quality of surgical margins achievable with the use of navigated Intraoperative CT

Condition or Disease	Intervention/Treatment	Phase
Neoplasms Muscle Neoplasm	Diagnostic Test: evaluate the quality of surgical margins achievable with the use of navigated Intraoperative CT

Study Design

Study Type:

Observational

Anticipated Enrollment :

45 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Orthopedic Oncology Surgery: Navigation, Intraoperative Imaging and Virtual Reality

Actual Study Start Date :

May 17, 2022

Anticipated Primary Completion Date :

May 17, 2025

Anticipated Study Completion Date :

Nov 17, 2025

Arms and Interventions

Arm	Intervention/Treatment
Popolation	Diagnostic Test: evaluate the quality of surgical margins achievable with the use of navigated Intraoperative CT Noninterventional, prospective study of patients operated on for musculoskeletal neoplasms designed to evaluate the quality of surgical margins achievable with the use of navigated Intraoperative CT

Arm

Intervention/Treatment

Popolation

Diagnostic Test: evaluate the quality of surgical margins achievable with the use of navigated Intraoperative CT

Noninterventional, prospective study of patients operated on for musculoskeletal neoplasms designed to evaluate the quality of surgical margins achievable with the use of navigated Intraoperative CT

Outcome Measures

Primary Outcome Measures

Quality of life [Baseline]
To evaluate the quality of the Surgical Margin in terms of the percentage of oncologically adequate resections, in patients with Musculoskeletal neoplasms undergoing navigated resection surgery with Intraoperative CT

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age: no limit
Patients with musculoskeletal neoplasms predominantly in complex sites
Patients who will have to undergo surgical resection/amputation for the management of their clinical case
Preparation of preoperative planning discussed at DMT
Surgery performed with the aid of Intraoperative CT Navigated
Written informed consent

Exclusion Criteria:

Inability to perform pre-post treatment assessment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	"Regina Elena" National Cancer Institute	Rome		Italy	00144

Sponsors and Collaborators

Regina Elena Cancer Institute
Azienda Policlinico Umberto I
Istituto Ortopedico Galeazzi

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Regina Elena Cancer Institute

ClinicalTrials.gov Identifier:

NCT05918536

Other Study ID Numbers:

RS1686/22

First Posted:

Jun 26, 2023

Last Update Posted:

Jun 26, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neoplasms

Muscle Neoplasms

Study Results

No Results Posted as of Jun 26, 2023