Intracranial Neoplasm, Pelvic Bone Neoplasm, Sarcoma
Conditions
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.
Interventions
DEVICE3D 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.
Sponsors
Kathleen McGreevy
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Oncologic patients
Eligibility
Sex/Gender
ALL
Age
7 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3D model feasibility for pre-surgical making decisions | through study completion, an average of 1 year | Number of cases in which the time interval between prescription and delivery of the device exceeds 20 days |
| Surgical time | through study completion, an average of 1 year | 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. |
| Device feasibility | through study completion, an average of 1 year | 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). |
Countries
Italy
Contacts
Primary ContactKathleen McGreevy, PhD
Outcome results
None listed