SarcomaNCT06291662
Evaluation of Performance Characteristics and Applicability in Oncology of Devices Customized Medical Devices Made by 3D Printing
A study testing 3D printer applications in people with Sarcoma and Intracranial Neoplasm, run by Kathleen McGreevy at 3 sites in Italy.
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… Read more about this study
- Who is it for?
- Ages 7 to 70 years
- Conditions the study is for
- Sarcoma, Intracranial Neoplasm, Pelvic Bone Neoplasm
- What is being tested?
- 3D printer applications
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 3 sitesItaly
- Study dates
- 1 Jan 2021to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- inoperability;
- presence of pathological fractures.
Trial locations and contacts
3 sites in 1 country.
Italy3 sites, 1 recruiting
- Active, not recruiting
Azienda Ospedaliero-Universitaria Careggi (AOUC)
Florence
- Recruiting
Meyer Children's Hospital IRCCS
Florence
Federico Mussa, MD, federico.mussa@meyer.it
- Active, not recruiting
Azienda Ospedaliero Universitaria Senese (AOUS)
Siena
About this study
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
- Being tested
- 3D printer applications
- Medical subject headings
- Sarcoma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D printer applicationsDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: 3D printer applications |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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).
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start1 Jan 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Oncologic patients
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kathleen McGreevy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kathleen McGreevy, Meyer Children's Hospital IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06291662
- Sponsor's protocol ID
- PRECISE_IC
- Status last verified
- Feb 2024
- First submitted
- 19 Feb 2024
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Performance Characteristics and Applicability in Oncology of Devices Customized Medical Devices Made by 3D Printing
- ClinicalTrials.gov ID
- NCT06291662
- Acronym / sponsor ID
- PRECISE_IC
- Conditions
- Sarcoma, Intracranial Neoplasm, Pelvic Bone Neoplasm
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Kathleen McGreevyUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 4 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Oncologic patients
| Arm | Type | Receives |
|---|---|---|
| Pelvic bone neoplasm | Experimental | Device: 3D printer applicationsPatients 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. |
| Sarcoma pediatric patients | Experimental | Device: 3D printer applicationsPatients with primary sarcoma of bone and soft parts involving the scapula, the pelvis and upper and lower limbs; brain tumor. |
| Intracranial oncologic pathology | Experimental | Device: 3D printer applicationsPatients with intracranial oncologic pathology with bone involvement and lesions of the skull theca primary or secondary. |
Who may qualify
- Ages
- 7 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- inoperability;
- presence of pathological fractures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D printer applicationsPatients 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. | Device | Intracranial oncologic pathology, Pelvic bone neoplasm, Sarcoma pediatric patients |
Primary outcome
3D model feasibility for pre-surgical making decisions
Time frame: 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
Time frame: 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
Time frame: 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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D printer applications in people with Sarcoma and Intracranial Neoplasm, run by Kathleen McGreevy at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kathleen McGreevy, PhD (055 5662644, kathleen.mcgreevy@meyer.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3D model feasibility for pre-surgical making decisions (time frame: through study completion, an average of 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2024.