Evaluation of Performance Characteristics and Applicability in Oncology of Devices Customized Medical Devices Made by 3D Printing

NCT ID: NCT06291662

Last Updated: 2024-03-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2025-06-30

Brief Summary

Technologies 3D are demonstrating enormous potential for innovation in the field of surgery,introducing the concept of "treatment customization" (from planning surgery to implant design and manufacturing) on the patient's anatomy, simply by taking advantage of the patient's own common diagnostic images and the flexibility of 3D printing. In fact, this new construction technology allows the construction of the complex anatomical geometries with economy, simplicity and on scales of production unattainable by other traditional technologies. This new construction technology allows, in fact, the construction of complex anatomical geometries with economy, simplicity and on scales of production unattainable by other traditional technologies.

Conditions

Sarcoma; Intracranial Neoplasm; Pelvic Bone Neoplasm

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Intracranial oncologic pathology

Patients with intracranial oncologic pathology with bone involvement and lesions of the skull theca primary or secondary.

Group Type: EXPERIMENTAL

3D printer applications

Intervention Type: DEVICE

Patients will undergo TC/MRI as per routinary care. Custom 3D-devices will be printed on the basis of these images. The device will be used to establish pre-operative surgical options in terms of tissue/bones demolition/reconstruction.

Pelvic bone neoplasm

Patients with primary tumor of the pelvic bone; Primary meta-diaphysial tumor of the long bones; squamous cell carcinoma of the oral cavity involving the maxillary upper and/or lower.

Group Type: EXPERIMENTAL

3D printer applications

Intervention Type: DEVICE

Patients will undergo TC/MRI as per routinary care. Custom 3D-devices will be printed on the basis of these images. The device will be used to establish pre-operative surgical options in terms of tissue/bones demolition/reconstruction.

Sarcoma pediatric patients

Patients with primary sarcoma of bone and soft parts involving the scapula, the pelvis and upper and lower limbs; brain tumor.

Group Type: EXPERIMENTAL

3D printer applications

Intervention Type: DEVICE

Patients will undergo TC/MRI as per routinary care. Custom 3D-devices will be printed on the basis of these images. The device will be used to establish pre-operative surgical options in terms of tissue/bones demolition/reconstruction.

Interventions

3D printer applications

Patients will undergo TC/MRI as per routinary care. Custom 3D-devices will be printed on the basis of these images. The device will be used to establish pre-operative surgical options in terms of tissue/bones demolition/reconstruction.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Primary tumor of the pelvic bone Primary meta-diaphysial tumor of the long bones; squamous cell carcinoma of the oral cavity in the upper and/or lower jaw. over 10 years of age
• Primary sarcoma of bone and soft parts involving the scapula, the pelvis and upper and lower limbs; brain tumor aged 7-18 years
• Intracranial oncologic pathology with bone involvement and lesions of the skull theca primary or secondary aged 18-70years
• signed informed consent form

Exclusion Criteria

• inoperability;
• presence of pathological fractures.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kathleen McGreevy

OTHER

Sponsor Role: lead

Responsible Party

Kathleen McGreevy

Chief Operating Officer, Meyer Children's Research Institute

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Azienda Ospedaliero-Universitaria Careggi (AOUC)

Florence, , Italy

Site Status: ACTIVE_NOT_RECRUITING

Meyer Children's Hospital IRCCS

Florence, , Italy

Site Status: RECRUITING

Azienda Ospedaliero Universitaria Senese (AOUS)

Siena, , Italy

Site Status: ACTIVE_NOT_RECRUITING

Countries

Italy

Central Contacts

Kathleen McGreevy, PhD

Role: CONTACT

kathleen.mcgreevy@meyer.it

055 5662644

Facility Contacts

Federico Mussa, MD

Role: primary

federico.mussa@meyer.it

Other Identifiers

PRECISE_IC

Identifier Type: -

Identifier Source: org_study_id