Using 3D printing to create customized medical devices for cancer treatment
Evaluation of Performance Characteristics and Applicability in Oncology of Devices Customized Medical Devices Made by 3D Printing
This study is testing whether 3D printed medical devices made just for cancer patients can improve their treatment and surgery results.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 7 Years to 70 Years |
| Sex | All |
| Sponsor | Meyer Children's Hospital IRCCS Academic / other |
| Locations | 3 sites (Firenze and 2 other locations) |
| Trial ID | NCT06291662 on ClinicalTrials.gov |
What this trial studies
This study evaluates the performance and applicability of 3D printed medical devices tailored for oncology patients. By utilizing patients' diagnostic images, the study aims to create customized implants that fit the unique anatomical structures of individuals with conditions such as sarcoma and intracranial neoplasms. The approach leverages the flexibility and precision of 3D printing technology to enhance surgical outcomes and improve treatment efficacy. Participants will undergo interventions involving these innovative 3D printed devices.
Who should consider this trial
Good fit: Ideal candidates include patients aged 7-70 with specific types of bone and soft tissue tumors or intracranial neoplasms.
Not a fit: Patients who are inoperable or have pathological fractures may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective and personalized treatment options for patients with complex tumors.
How similar studies have performed: While the use of 3D printing in medical applications is gaining traction, this specific approach in oncology is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Firenze and 2 other locations
- Azienda Ospedaliero-Universitaria Careggi (AOUC) — Firenze, Italy (Active_not_recruiting)
- Meyer Children's Hospital IRCCS — Firenze, Italy (Recruiting)
- Azienda Ospedaliero Universitaria Senese (AOUS) — Siena, Italy (Active_not_recruiting)
Study contacts
- Study coordinator: Kathleen McGreevy, PhD
- Email: kathleen.mcgreevy@meyer.it
- Phone: 055 5662644
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.