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

NCT06291662 | Recruiting

• 1 other identifier: PRECISE_IC
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (3)

• 3D model feasibility for pre-surgical making decisions

  Number of cases in which the time interval between prescription and delivery of the device exceeds 20 days

  through study completion, an average of 1 year

• Surgical time

  Number of procedures in which the surgical outcome can be considered optimal (taking planning as a reference) by comparing CT images and evaluating the margins at final histologic analysis.

  through study completion, an average of 1 year

• Device feasibility

  Proportion of failed surgeries due to a positive or contaminated finding of the margin of bone resection on final histological examination. verified by comparing the expected outcome (i.e., planning output) and the actual outcome (on the postoperative CT scan).

  through study completion, an average of 1 year

Study Arms (3)

Pelvic bone neoplasm

EXPERIMENTAL

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.

Device: 3D printer applications

Sarcoma pediatric patients

EXPERIMENTAL

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

Device: 3D printer applications

Intracranial oncologic pathology

EXPERIMENTAL

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

Device: 3D printer applications

Interventions

3D printer applications 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.

Intracranial oncologic pathology; Pelvic bone neoplasm; Sarcoma pediatric patients

Eligibility Criteria

• Age: 7 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• inoperability;
• presence of pathological fractures.

Sponsors & Collaborators

• Kathleen McGreevy: lead

Study Sites (3)

Azienda Ospedaliero-Universitaria Careggi (AOUC)

Florence, Italy

ACTIVE NOT RECRUITING

Meyer Children's Hospital IRCCS

Florence, Italy

RECRUITING

Azienda Ospedaliero Universitaria Senese (AOUS)

Siena, Italy

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Sarcoma; Brain Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Kathleen McGreevy, PhD

CONTACT

055 5662644; kathleen.mcgreevy@meyer.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Operating Officer, Meyer Children's Research Institute

Model Details: Oncologic patients

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: March 4, 2024
• Study Start: January 1, 2021
• Primary Completion: December 31, 2024
• Study Completion: June 30, 2025
• Last Updated: March 4, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3)