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

Sarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06291662
• Other study ID #: PRECISE_IC
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: June 30, 2025

Study information

• Verified date: February 2024
• Source: Meyer Children's Hospital IRCCS
• Contact: Kathleen McGreevy, PhD
• Phone: 055 5662644
• Email: kathleen.mcgreevy[@]meyer.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bone Neoplasms
• Brain Neoplasms
• Intracranial Neoplasm
• Neoplasms
• Sarcoma

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Italy	Azienda Ospedaliero-Universitaria Careggi (AOUC)	Firenze
Italy	Meyer Children's Hospital IRCCS	Firenze
Italy	Azienda Ospedaliero Universitaria Senese (AOUS)	Siena

Sponsors (1)

Lead Sponsor	Collaborator
Kathleen McGreevy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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